Medical line tension mitigation securement device

The invention relates to an apparatus, system and method to mitigate lines, tubes, and cords that are attached to a secure structure, such as a patient, from being displaced or pulled out from the insertion site of each line, tube, and cord on the patient when each line, tube and cord is pulled or yanked unexpectedly, as can routinely occur during patient movement, treatment, or therapy in a hospital, medical, or other environment.

CROSS REFERENCE TO RELATED APPLICATIONS

PCT Application No. PCT/US22/29348, filed on May 14, 2022;

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of the present disclosure relate generally to medical line tension mitigation and securement devices.

Clinicians and patients currently have no tools or products that can prevent line pulls (including IV tubing, cables, cords and the like) or dislodgement from patient insertion sites when patients need to be mobilized. Currently in the USA, 19 million lines pull out annually, and this issue is underreported. Mobilization includes transporting or moving patients; bed transfers; including clinicians moving around the patient or bed; patient tasks such as sitting up, standing, moving to a chair, walking to the bathroom; or performing rehabilitative therapy. Currently 64% of early mobility therapy in Intensive Care Unit (ICU) settings is spent detangling and securing lines.

Following invasive procedures or injury, early mobility therapy is one of the best ways of increasing the rate of healing. However, most patients with serious hospitalizations have multiple lines and cords and are connected to life saving medical equipment. During early mobility therapy, these connections pose real issues and barriers as patients experience discomfort, pain, and fear of significant injury. Once discomfort is felt, it is human nature to not repeat that same activity. So, if discomfort is felt from a line pulling on a line insertion site during therapy, the patient will not want to perform that therapy again which may hinder the patient's ability to heal. Or worse, lines are accidentally pulled out of a patient insertion site which may contain life support lines or diagnostic monitoring equipment required for life support. If a life support line is pulled out of an insertion site, patient death can occur unless emergency interventions are quickly and accurately performed. Several types of trauma, from mental fear, to physical pain, to the risk of death prevent the desire to perform the needed therapy that promotes healing.

Tapes or adhesives and sutured-in lines are the commonly used methods to secure lines at patient insertion sites onto patient skin. This has many drawbacks such as, nagging discomfort, skin tears, skin irritation, blemishes and skin infections. Adhesives provide only a minimal amount of strength to grip lines, between 4-9 lbs. (1.8-4.1 kg) of pull force can pull off typical adhesives. Clinicians have also used tape and medicine cups or tongue depressors to group IV lines and cords to bedrails or have used rolled up incontinence pads and taped IV lines to the pads and then pinned them to patient gowns for an attempt at minimal securement with limited success. Line pulls and pullouts are a known problem, and the mentioned solutions are the best that resourceful clinicians have come up with to attempt a means of controlling and providing some sort of safety to their patients. There is currently nothing available that is reliable, reusable, and will secure multiple IV lines, tubes and cords in a in single location while also providing tension mitigation of a pull force up to and over at least 9 lbs. (4.1 kg) of pull force applied to said line, tube, or cord.

SUMMARY OF THE INVENTION

It is the object of the invention to provide a device inserted between the attachment site of lines, tubes, or cords on a patient's body and the source of a pull force (such as by a tug or yank) on the lines, tubes, or cords, the device preventing displacement of each line, tube or cord at the patient attachment or insertion site, as can routinely occur during patient movement, treatment, or therapy in a hospital or medical environment.

Another object of the invention is to provide an apparatus that is comprised of a minimal quantity of parts which are easy to manufacture.

In accordance with a first embodiment, the invention relates to an apparatus which comprises an armband, a securement body attached to the armband, a securement strap configured to cause the securement body to displace, and a strap attached to the armband utilized to secure the armband to a secure structure, such as a patient, a bed, an IV pole, a crutch, etc. The securement body is configured to securely hold at least one line, tube, or cord and the strap may additionally secure at least one transducer or another device to the armband. Further, the armband is biocompatible with human skin and able to be worn by a patient for at least a day, but preferably up to or exceeding 30 days.

In accordance with a second embodiment, the securement body may secure a single line or multiple lines within a single securement body, further the the securement strap and securement body may be formed integral to each other.

In accordance with a third embodiment, the securement body may be a shape and material composition designed to provide mitigation of a specific amount of pull force, such as 9 lbs. (4.1 kg) or 20 lbs. (9.1 kg) or even 70 lbs. (31.8 kg) or more.

The invention also relates to a method for mitigating the undesired removal of lines, tubes, and cords attached to a patient beginning with securing the securement device with a securement strap, at least one grip channel, and at least one a flange, wherein the flange is extending toward the top of the securement body, around a secure structure, such as a patient's arm, in an orientation so the flanges and slots of the securement device are facing upward. Next, the patient attached lines, tubes, and cords at patient insertion sites are each attached to the securement device. Last, the securement body is put under compression causing each flange to touch the neighboring flange and each slot width to reduce, thereby securing the securement device to each line, tube and cord so if any of the secured lines, tubes, or cords are yanked or pulled, each line, tube, and cord inserted into the patient will remain in place at their insertion sites, unaffected, as the pull force from the yank or pull is mitigated by the device.

DETAILED DESCRIPTION OF THE INVENTION

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. Although some suitable dimensions, ranges, and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges, and/or values may deviate from those expressly disclosed.

As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the terms “and” and “or” are generally employed in its sense including “and/or” unless the content clearly dictates otherwise. It is to be noted that in order to facilitate understanding, certain features of the disclosure may be described in the singular, even though those features may be plural or recurring within the disclosed embodiment(s). Each instance of the features may include and/or be encompassed by the singular disclosure(s), unless expressly stated to the contrary.

As used herein, the terms “lines,” “tubing,” “IV,” and “cords” are intended to be interchangeable and mean any flexible medical grade material used to carry fluid, gas, information, or electricity.

A medical line tension mitigation securement device, system, and method will now be described with references inFIGS.1-13. Turning to the drawings, where the reference characters indicate corresponding elements throughout the several figures, attention is first directed toFIG.1where an enlarged rear perspective view of an embodiment of the present invention is shown, illustrating its composition, the apparatus is generally indicated by reference character100. Medical line tension mitigation securement device100is designed to eliminate hazardous pulling and line or cord dislodgement from a patient during therapy, transport, and patient movement. Securement device100may be single use or reusable with the current embodiment being tested to operate effectively for up 30 days. Securement device100is configured to secure and organize one or more various sized and type of medical tubes, lines, and cords along a X, Y, and Z axis against pull forces along the X, Y, and Z axis. Securement device100is also designed to include a minimal set of components that are easily manufacturable and provide a much-needed solution to a recognized clinical problem, undesired tube or cord removal from patient insertion sites, potentially causing tube or cord attached equipment malfunction, patient pain and in some cases, death. The simplicity and optimization of securement device100is the outcome of 30+ iterations of design and thousands of hours of effort. Securement device100comprises a line securement body102comprised of a tacky elastomer material that is affixed to a flexible securement band104, such as an armband (which will be used to refer to element104, however it should be noted armband104is not limited to securement around a patient's arm). In the preferred embodiment line securement body102is permanently attached to armband104(such as by molding, adhesive, Velcro®, sewing, ultrasonic welding, or other methods), although it may be removable or adhered together using known methods to fix two or more dissimilar materials together. Securement device100further comprises a securement strap106wrapped around securement body102, wherein securement strap106is configured to provide a variable amount of tension to securement body102while also preventing cords or lines held by securement body102from moving or being pulled out of the securement body (seeFIG.10). Additionally, securement device100further comprises a strap118which extends through securement body102and comprises a first end108configured to removably connect to armband104to tighten and secure armband104around a user's arm, or other secure structure, while strap118also comprises a second end110configured to secure to armband104. Second end110may also be configured to secure at least one transducer (seeFIG.8andFIG.9), and preferably 3, to armband104.

Armband104comfortably wraps around a secure structure, such as a patient's appendage, such as an arm or leg, much like a blood pressure cuff, and without adhesives. It should be noted that securement device100, via armband104, may be configured by subtle shape modifications to securement body102, to mount to a patient other than by an arm or leg, such as the case with ECMO tubing, femoral catheters, Swan Ganz, oncology, labor and delivery, breathing tubing, Flight for Life, neo-natal ICU (NICU), military or other desired situations for line tension mitigation. Armband104can also be mounted to almost any rigid body, such as, but not limited to, an IV pole or bedrail and is intended to travel with the patient. Strap118is used to tightened and secure armband104around the arm, or other securement structure. Strap118must be properly secured with the appropriate tension to armband104in order to keep armband104from moving along the securement structure, such as a patient's arm, which may also require a different tension for each patient. It is contemplated the length and width of armband104may be varied to accommodate a specific patient characteristic, such as for bariatric, pediatric, or neonatal patients.

Turning toFIG.2andFIG.3, a front exploded view of an embodiment of the present invention and a perspective view of a fully assembled embodiment of the present invention is shown. Armband104is further comprised of at least an upper layer120with a body aperture124formed therethrough and configured to allow a portion of securement body102to extend through it wherein a portion of body102(base112, first portion130, and second portion132described below) remain below upper layer120, and a lower layer122located below upper layer120and securement body102, and an adhesive located between upper layer120and lower layer122(and the portion of securement body102between upper layer120and lower layer122) to adhere the layers together (preferably permanently) with body102, thereby securely sandwiching securement body102(via first portion130and second portion132described below) to armband104. Body aperture124is the shape of the perimeter of securement body102without first protrusion130or second protrusion132(described below) of base112along the X and Y axis (in the XY-plane) (the perimeter of flanges150, first termination end114, and second termination end116described below), which is rectangular with rounded corners with the longest sides being curvilinear. Body aperture124is oriented to have its longest side extend across the width (X-axis) of armband104, although aperture124may be located in an alternative location and position on armband104if desired to operate with securement body102. Upper layer120is comprised of foam (or other flexible material such as fabric, plastic, etc.) with a top surface134, wherein top surface134is covered with a loop fastener (not shown), such as Velcro®. Top surface134further comprises artwork140printed on, embossed with, or otherwise made viewable on top surface134of upper layer120to indicate the appropriate orientation of device100when securing to a patient. The orientation of securement body102is important for optimizing tube or cord securement during tugging as the orientation of securement body102attributes to the ability of securement device100to prevent cord or cable pullout from tugging from various directions (described more below). In the current embodiment, the artwork140includes the text “UP” with an arrow graphic is located near one edge of the top surface of upper layer120to indicate device100should be oriented so the artwork140is located closest to, and aiming towards the direction of a patient's head, or the top of the securement body. The direction coincides with the direction of securement body flanges150and corresponding slots144(discussed below). Armband104further comprises at least one score mark164, but preferably a plurality, located across the width and in various locations along the length of upper layer120and lower layer122and configured to allow armband104to be flexible to easily wrap and secure around a secure structure.

Lower layer122is preferably comprised of a USP Class VI medical grade and skin biocompatible material configured to reduce or eliminate pressure sores which may develop on a patient from extended wearing of device100, as well as provide a non-absorbent barrier against sweat and moisture. To apply armband104to a patient, armband104is applied around a patient's arm with direct skin contact, not over clothing. Lower layer122may also be comprised of foam (or other comfortable flexible material) and is configured to provide a useful amount of friction as to not slide freely along the surface of the skin (similar to the tension provided by flexible neoprene knee brace to remain in position) and does not require excessive tightening or retightening to stay in place. Armband104(via upper layer120and lower layer122) in the current embodiment is about 17.75 in. (450.85 mm) long along the Y-axis and 4 in. (101.6 mm) wide along the X-axis with a score mark164located about every 1 inch (25.4 mm) along the length of armband104with the center of body aperture124located about 2 in. (50.8 mm) from one lengthwise end of armband104.

Strap118is preferably comprised of Velcro® hook fastener material on at least one side with first end108being wider (about 1.88 in. (47.75 mm)) along the X-axis and longer (about 3 in. (76.2 mm)) along the Y-axis than second end110(about 0.75 in. (19.1 mm) wide along the X-axis by 2.75 in. (69.9 mm) long along the Y-axis in order to provide more surface area to adhere the hook fastener material of strap118to top surface134of upper layer120, although the dimensions of first end108and second end110may be altered if desired. The hook fastener material of strap118faces toward top surface134of armband104to ensure removable adherence of strap118to armband104. Strap118further comprises a middle portion152located in between first end108and second end110and has a length (along the X-axis) and width (along the Y-axis) less than the length and width of strap aperture148of securement body102(described below), however other dimensions as desired may be used. In the preferred embodiment middle portion is wider then first end108, but can be the same width as first end108if preferred.

Turning toFIG.4, a front view of an embodiment of the present invention is shown. Line securement body102comprises a base112with a first termination end114connected on one side of base112and a second termination end116connected on the other side of base112, and at least one securement flange150, with seven shown in the present embodiment, located in-between (or sandwiched between) first termination end114and second termination end116and formed integral with and extending away from base112, wherein each flange150is located in-line with one another and first termination end114and second termination end116. Securement body102further comprises at least one grip channel142formed therethrough base112along the Y-axis and primarily circular or cylindrical in shape and configured to hold at least a portion of a tube, line, or cord. Other lines and cords besides IV lines may be inserted into similarly sized grip channels142such as oxygen tubes or electrical cables like pulse-oximetry lines, which are flexible but rigid radially and cannot be crushed like hollow fluid lines. These other lines or cords may be different sizes depending on the application as previously mentioned. Grip channel142is located between first termination end114and the at least one flange150, between the at least one flange150and another flange150, and between a flange150and the second termination end116. Each grip channel142is further connected to a slot144which extends away from the grip channel142, wherein slot144is configured to allow a tube, line, or cord to slide through said slot into the corresponding connected grip channel142. Each slot144is defined by a flange150and another flange150, a flange150and a first termination end114, or a flange150and a second termination end116. The overall shape of first line securement body102is purposefully curvilinear, in the XZ-plane, along the tops of first termination end114, each flange150, and second termination end116in order to utilize the concept of hoop stress (described below) to ensure securement body102adequately secures tubing within grip channels142by applying force to a held line or tube around the circumference of the held line or tube. Securement body102is also curvilinear shaped in the XY-plane (seeFIG.6) with the flange150located at the center point of body102the longest (along the Y-axis) with each subsequent flange150toward first termination end114and second termination end116reducing in length (along the Y-axis) to create a tapering effect (in part for at least ornamental design reasons) (seeFIG.6). Securement body102is symmetrically shaped along the XZ and XY-plane in the current embodiment. In addition, if there is more than one flange150attached to base112, all of the flanges150may be varied lengths, preferably symmetrical along the X-axis about a central flange150that centrally located on securement body102and is the tallest as compared to the other flanges150. In the current embodiment base112is about 3.13 in. (79.4 mm) in length (along the X-axis), and a width varying from about 1.5 in. (38.1 mm) at the center of base112length tapering to 1.25 in. (31.8 mm) wide at first termination end114and second termination end116(flanges150follow this width range as well with a thickness ranging from 0.125 in. (3.18 mm) to about 0.25 in. (6.35 mm) and slot144length varying between about 0.125 in. (3.18 mm) and 0.75 in. (19.05 mm)) however these dimensions may be altered if desired for such reasons as including, but not limited to: varying line quantity secured by securement body102(by changing grip channel142quantity), variation in force applied to secured lines, and variation in secured line diameter. Each slot144is preferably straight (as defined by two securement flanges150next to each other, a segment flange150and first termination end114, or a flange150and second termination end116) but can be curvilinear or varied in shape if desired (seeFIG.13). It is important to note that while grip channel150is preferably circular or cylindrical (to accommodate at least a portion of circular or cylindrical tubing) but could be other shapes to accommodate other shaped flexible tubing. The diameter of a grip channel150is specific for a specific range of IV-line, tubing, or cord diameters to ensure proper and optimal securement. While medical tube lines and cords do not follow standard size guidelines, there are similarities between manufacturers that are in a tight enough size range that an average nominal line size could be determined as common for significant enough sized tubes, lines, and cords to warrant a value to be used in creating a common grip channel142size to house each range of tubes, lines, and cords. There are an infinite range of lines, tubes, and cords as well, but the nominal grouping chose in the current embodiment is about ⅛″ (or close to 3 mm) and about ¼″ (or close to 6 mm). Each grip channel142in securement body102accommodates the width of slot144needed for manufacturability of securement body102(preferably via injection molding or other molding process) and to allow insertion of tubes matched to a particular grip channel150diameter so that the grip channel150size, when securement body102is in its constraining state, via tightening of securement strap106, each slot144is closed or minimized by each flange150, flange150and termination end114or116touching, so grip channel142matches this nominal ⅛″ and ¼″ diameter size so grip channel142touches the outer surface of the held tubing around its circumference. A secure fit of tubing to grip channel142is critical as the grip channel142size that most closely matches the tube, line, or cord will yield the greatest effect on restraining line tension (and preventing pullout of the tube in patient insertion sites). It is contemplated a grip channel142may comprise other nominal diameter sizes and line securement body102may contain any desired number of securement flanges150and thus grip channels142and slots144as desired for a specific application. Similarly, grip channel142should be as close to a circle in shape as possible to provide a uniform load around the held tubing to exhibit a strong grip all around the secured tubing and to prevent fluid restriction within the tubing. In the event that grip channel142is an oval, square, triangle, or anything besides a circle (assuming a circular tube is being held by grip channel142), the gripping force exerted on tubing held within grip channel150will not be consistent around the circumference of the tubing and will thus be weaker than compared to a circle. First termination end114located on one end of secure body102(along the X-axis) and is generally curved or partially tear drop shaped on one side and may also comprise a flange150, while second termination end116is located on the opposing end of secure body102(also along the X-axis) and is generally curved in the opposite direction as first termination end114and may include an extension168protruding in the opposing direction as flanges150, wherein extension168helps to form a grip channel150and slot144between termination end116and neighboring flange150.

If a pull force occurs (IV, line, tubing, or cord becomes tugged or yanked) on a line which has been secured to a grip channel142via compression of body102by securement strap106, the pull force is mitigated at the device100by channeling the pull force from device100to the securement structure (patient's arm for example), leaving the patient's insertion site unaffected. Securement device100easily mitigates 20+ lbs. (9.1 kg) of pull force (see below for further description), and preferably up to 80+ lbs. of pull force. To give some context regarding the important of mitigating at least 20+ lbs. (9.1 kg) of pull force, central venous catheters can pull out with between just 4-9 lbs. (1.8-4.1 kg) of pull force. Further, due to the design of device100, it does not crush or crimp lines, allowing for safe fluid flow even under significant gripping conditions.

Base112of securement body102further comprises a strap aperture148formed therethrough and configured to allow strap118to extend through strap aperture148. Strap aperture148is positioned above upper layer120of armband104to allow movement of strap118through strap aperture148for various needs of a user (such as installing one or more transducers on first end of strap118or to provide additional length to armband104for a securement purpose. In the current embodiment strap aperture148is about 1 inch (25.4 mm) along the X-axis and about 1.5 in. (38.1 mm) along the Y-axis, however strap aperture148may be changed in size and configuration if desired. Strap aperture148is rectangular with rounded corners and about 0.0625 in. (1.59 mm) tall along the Z-axis, about 1 in. (25.4 mm) along the X-axis, and 1.56 in. (39.6 mm) along the Y-axis, but can be configured into a different shape and dimensions as desired.

Turning toFIG.5andFIG.6, a perspective view and a top view of an embodiment of securement body102is shown. Securement body102further comprises a first protrusion130connected to base112and extending away from base112(along the Y-axis), perpendicular to each flange150and parallel to each grip channel142, and a second protrusion132connected to base and extending away from base112(along the Y-axis), perpendicular to each flange150and parallel to each grip channel142, wherein the second protrusion132is a mirror image of the first protrusion130and located on the opposite wall of first protrusion130. Both first protrusion130and second protrusion132are generally rectangular with rounded corners but could be configured into a different shape and configuration as desired per other potential methods for optimal bonding to armband104. First protrusion130and second protrusion132are configured to be sandwiched between upper layer120and lower layer122and secure securement body102to armband104, preferably permanently. The securement of body102to armband104is important and significant to ensure device100can withstand the 20+ lbs. (9.1 kg) of pull force on secured tubing, lines, or cables within grip channels142and transfer the pull force to the securement body102the device100is attached to. Turning toFIG.6, as mentioned above, the widths of flanges150, first termination end114, and second termination end150can vary, in the current embodiment they form a generally curvilinear shape. The bottom of base112is flat (although due to the material securement body102is produced from base112is flexible) in order to allow easy part measuring for improved quality assurance practices during molding/manufacturing and also to allow easy tooling to assemble and bond to upper layer120and lower layer122but is flexible enough to allow securement body102to deform when put under tension by securement strap106, allowing flanges150overlap each other (and/or first termination end114and second termination end116), slots144reduce in size, and grip channels142pressing against the portions of secured tubes secured within grip channels142, causing securement body102becomes symmetrical or nearly symmetrical in shape along the XZ-plane, thus providing more uniform hoop stress (uniform compression forces/load applied around the circumference of the tubing portion held within securement body102which provides optimal tension mitigation by device100from tubing pull forces) on secured tubing within grip channels142(see.FIG.7B).

Turning back toFIG.2andFIG.4, securement strap106is comprised of a flexible material with a top surface154, a bottom surface156, and a buckle138fixed to one end. Securement strap106further comprises a hook fastener portion128located on bottom surface156located near the end of strap106opposite of buckle138and extending toward buckle138, about 2.5 in. (25.4 mm) in the current embodiment (however other sizes may be used), and a loop fastener portion146also on the bottom surface156extending from buckle138to loop fastener portion146, about 6.5 in. (165.1 mm), but can be other shapes as desired. It should be noted the width of securement strap106is important as the width of the current embodiment is about 1 inch (25.4 mm) and it has been found with the current size characteristics of securement body102, a width of securement strap106less than 1 inch (25.4 mm) increases the pressure placed on secured lines in each grip channel142as compared to a securement strap106width of 1 inch (25.4 mm) with the same tension force (about 10 lbs. (4.5 kg) in the current embodiment), which can be useful in some embodiments. In use, securement strap106surrounds and tightens itself against securement body102in the XZ-plane, thereby causing flanges150to touch or overlap and securement body102to compress around tubing contained within each grip channel142, thereby securing the tubing from moving within securement body102due to a yank or tug. Top surface154of securement strap106comes into slidable contact with the securement body102along the XZ-plane, and securement strap106threads through buckle138so that loop fastener portion146is in contact with hook fastener portion128at the desired tension, however it is contemplated at least a portion of securement strap106may be fixed to securement body102or armband104. The tension securement strap106applies to securement body102is variable and dependent on the length of securement strap106threaded through buckle138. While other types and brands of material may be used for loop fastener portion146and hook fastener portion128, Velcro® brand is preferred. Further, securement strap106remains slidable between the bottom of base112and lower layer122of armband104to allow the variable tension to be applied to body102. Securement strap106is ideally comprised of Velcro® but other securement strap methodologies known in the art may be employed, such as zip ties, a string, a clamp, a clasp, or an elastomer closure strap.

It was found during pull force testing of lines, tubes, and cords secured within securement device100that the direction of each slot144(and thus each flange150), which allows insertion or removal of each line, poses a slight weakness in securement body102when a pull force is applied in the same direction and alignment as slot144, even when securement body102is under compression by securement strap106. So, as patients and their arms are statistically upright during sitting, standing, and therapy, each slot144and securement flange150, when device100is secured to a patient, is configured to face upward, toward the top of the arm (or a person's head) in order to reduce the likelihood of a pull force on a line secured in device100along the direction of a slot since most line pulls are downward due to gravity (toward the floor). As such, each slot144are oriented in the least likely direction for a line pull to occur where maximum line securement retention exists. Additionally, the angle of the each securement flange150(and thus each slot144) allows for each securement flange150to overlap the neighboring securement flange150or second termination end116(and to allow first termination end114to overlap neighboring flange150) and provide a compressive load on any IV lines, tubes, or cords within each grip channel142when the securement strap106is tightened down (for example 10 lbs. (4.5 kg) of strap force may be adequate to provide at least 20 lbs. (9.1 kg) of pull force mitigation on a line or tube secured within a grip channel142), rather than potential buckling of the line, tube, or cord if the each securement flange150(and thus each slot144) were purely vertically (or perpendicular to base112) oriented.

Turning toFIGS.7A and7B, a a left side view of an embodiment of securement body102without first portion130and second portion132before compression from securement strap106and after compression by securement strap106(not shown) is shown. After numerous tests, the preferred angle of securement flange150to allow ease of cord insertion, cord removal, and maximum cord securement due to the uniform overlapping nature of flanges150over each other to secure lines within each grip channel142to transmit the compressive loads through the body when under load is between 20 and 50 degrees (in relation to base112) without securement strap106tightened, and about 35 degrees (in relation to base112) when the securement strap106is tightened, and compressive load is applied to any IV lines, tubes, or cords within each grip channel150. It is contemplated the angle of each securement flange150may vary depending on what is desired to be secured, the common direction of pull forces to occur, the material of line securement body, and the diameter size of the grip channels.

Securement device100is an elastomeric system that uses a tension setting by way of securement strap106around securement body102that distorts the securement body102to then apply a compressive load generated by securement strap106to IV lines within the grip channels150in an analog, or infinitely adjustable, tension level between an open state and a closed state by holding the IV lines with a high degree of force without compressing them by way of a pinch or in a manner to disrupt fluid flow within the flexible line. Further, as mentioned above, first termination end114and second termination end116sandwich the securement flanges150wherein first termination end114, second termination end116and flanges150are all located in-line with one another and configured in a curvilinear shape. This type of shape, while having ornamental and aesthetically pleasing characteristics, also allows securement body102to grip onto IV lines, tubes, and cords securely. This type of shape acts to carry and transmit loads (pulls or yanks on the IV lines, tubes, and cables) held in each grip channel142in a more uniform manner by gripping more surface area of held lines, tubes, and cables. When securement strap106is tightened to cause compression of the securement body102to surround and grip the IV lines, tubes, or cables (in grip channel150), securement body102displaces significantly to a balanced shape, providing equal force applied to each line secured in each grip channel150around each grip channel. Securement strap106closes each slot144between each flange150, first termination end114, and second termination end116, which were used to install the lines into grip channels142initially, causing line securement body102to become a more uniform oval shape (seeFIG.7B). This oval shape then transmits the securement strap106force to the IV lines, tubes, or cables through a physics phenomenon known as hoop stress. A cylindrical, or circular shape of body102would be a theoretically ideally balanced and provide the highest amount of strength on all lines in such an embodiment (depending on the width of slots144allowing the lines to be inserted), but is likely not comfortable on a patient, and would make for a large and awkward device to be attached based on its size or height from armband104. In the event that a maximum amount of securement is desired, and device100wouldn't necessarily be flush against a patient's arm, a circular shape of securement body102may be desirable for the greatest ability to resist pull forces. So, a curvilinear or modified-semi-circle shape of securement body102combined with the armband104provides the best balance of manufacturability, weight, size, performance, and patient comfort for securement of lines, tubing, and cords. Alternatively, it is contemplated the curvilinear curvature in at least the XZ-plane mentioned above may be altered as desired. The greater the amount of curvature of flanges150, first termination end114, and second termination end116of securement body102, when in its secure and compression state (securement strap106is tightened and securement flanges150overlap each other), the greater the amount of resistance can be translated onto secured IV lines with grip channels150, tubing, or cords in the event of a line pull.

While securement body102is a tacky elastomer material, the key is the balance between the ease of tube insertion, safety, and comfort to the patient and the strength of device100to hold compression on the inserted tubes to prevent movement of the inserted tubes in securement body102by up to at least 9 lbs. (4.1 kg) of pull force, but preferable 20 lbs. (9.1 kg). The material properties of securement body102may be altered if desired for different situations. For example, in the event of a flight-for-life or military application and extra securement is desired, the shape could be changed for greater overall grip on inserted tubing, or the hardness of the material of securement body102could be changed to increase the strength of the grip around held lines at the expense of installation ease. In the preferred embodiment, the device100can withstand at least 20 lbs. (9.1 kg) of pull force in any direction (along the X, Y, or Z axis) but preferably up to 80 lbs. (36.3 kg) or more between all of the lines held by the device (assuming a force of about 10 lbs. (4.5 kg) is used to secure securement strap106around body102). That is, the device would mitigate 20 lbs. (9.1 kg) of force applied to one line secured in a grip channel142, or 5 lbs. (2.3 kg) of force applied to each of 4 lines secured in four grip channels142. The ability of the device to withstand a pull force of 20 lbs. (9.1 kg) or more is a substantial improvement over any current solutions and has been a long-standing problem to be solved. However, it is important to note that the amount of pull force device100can mitigate depends on a number of factors, including, but not limited to, the securement strap106tension applied to securement body102, the diameter of the cords, lines, and tubes being secured within grip channels142, and whether the lines, tubes, and cords are rigid/stiff or flexible/pliable. In addition, the directional vector of the pull force applied to the lines, tubes, and cords and the rate of speed at which the pull force is applied can be a factor.

Turning toFIG.8andFIG.9, a front perspective view of an alternative embodiment of the present invention with a transducer158attached to upper layer120of armband104via first end108of strap118, and a perspective view of the alternative embodiment of the present invention attached to a patient is shown. Transducer158further comprises a base160with at least one transducer aperture162located on at least one side of transducer base160configured to allow first end108of strap118to thread through at least one transducer aperture162, thereby securing transducer158to upper layer120via hook fastener of first end108affixing to loop fastener on top surface134of upper layer120of armband104. First end108of strap118is presently configured to secure up to 3 transducers158in-line with one another to armband104, however first end108may be made longer or shorter to accommodate a different quantity of transducers158or other desirable devices to be secured to securement device100. Turning toFIG.11, the location and position of first end108of strap118is important for transducer use as each transducer158, via armband104placement on a patient, device100allows correct positioning of transducer158to be in-line or level with the right atrium of a patient's heart230(see dotted line), which is critical for correct monitoring of life support medications via transducer158based on real-time blood pressure readings. Transducers were designed to be placed on IV poles but are more commonly attached to patient gowns with a clothespin, or taped to their arm, or through using a product that was intended to hold catheters in place on a patient's legs, which unfortunately falls down the patient's arm regularly, causing unnecessary potentially life-threatening disruptions. None of these methods can appropriately secure the transducer in the correct position as mentioned above by device100, which is crucial for proper hemodynamic monitoring after operations such as open-heart surgery or transplants.

Turning toFIG.10andFIG.11, a perspective view of the alternative embodiment of the present invention connected to a patient and secured to a stationary object is shown. Ultimately, medical line tension mitigation securement device100is a tension mitigation, or strain relief, device and system, where the device translates tension in the IV lines from a force vector, such as a yank or tug, to device100on the patients arm and not to the IV-line insertion site into the patient, providing a unique ability to prevent painful line pulling and dangerous dislodgement at patient insertion site(s). An example of this is illustrated inFIG.10where device100separates at least one line222(four lines in the current embodiment) attached to a patient into a load side224and a secure side226. When the lines on load side224of device100experience a force vector, such as a tug, device100absorbs and translates the force vector to the patient's arm instead of transferring to the secure side226of the lines, which are connected to patient insertion sites (locations where a line is attached to or extends into a patient's skin or body), thereby potential preventing pain and injury to the patient from the force vector. When secured lines222are not under load, securement device100is still constantly applying a compressive grip force to lines222that the patient does not feel. That is, a compression load, via securement strap106, is constantly being applied to hold the IV lines222in place by securement body102, and that compression load is independent of armband104surrounding the patient's arm, ensuring device100is always ready to protect against a tug or yank. That is, the compression load on body102is independent (and can be adjusted independently) of the force used to tighten armband104around the patient's arm. The compression load on securement body102from securement strap106forces securement body102into an oval shape which promotes even distribution of compression load on any secured lines222around the circumference of each line222, ensuring a strong grip on each line222. However, when an external tension or pull force is applied to lines222secured within body102, that load is translated to the securement body102performing the compression load onto the lines, which is translated onto armband104, which is then transferred to the patient arm (or other secure structure). Turning toFIG.11, device100is secured around a pole, such as an IV pole, via armband104.

Turning toFIG.12AandFIG.12B, a perspective view of another alternative embodiment of the present invention in an open and a closed (or compression) position is shown. In this alternative embodiment, armband104may comprise one or more individual securement bodies200, secured to armband104in the same manner as securement body102(via sandwiching a first and second protrusion (not shown) located on the base212of body200between upper layer120and lower layer122of armband104). Securement body200comprises a base212with a securement strap202formed integral to securement body200(replacing securement strap106on the previous embodiment), a single securement flange204and a single termination end206forming a grip channel214and a slot216, wherein securement strap202, securement flange204, and termination end206are all connected to base212. Termination end206further comprises a protrusion208extending away from securement flange204. Securement strap202further comprises at least one opening210formed therethrough and configured to secure over protrusion208, which is essentially a hook feature to hold onto opening210. Varied tension may be applied to securement body200by securing different openings210, where an opening210formed closer to where securement strap202is connected to base212would yield greater tension on securement body200and an opening210formed in securement strap202formed further away from base212would yield reduced tension on securement body202. Such an embodiment allows for a single line to be removed or adjusted in a particular securement body200without affecting the tension of any adjacent securement bodies200, or the lines they secure, should multiple securement bodies200be located on a single armband104. In the open position, a line may be placed into grip channel214via slot216. In the closed position, line is secured in grip channel214when securement strap202overlaps securement flange and termination end206, thereby positioning opening210of strap202over protrusion208of termination end206, thereby providing tension on securement body200and any held line in grip channel214. In addition, in any embodiment, it is contemplated the width of each slot216of securement body202could be increased or modified in conjunction with modification to the shape or material choices of body202to allow easier insertion of IV lines, tubing, or cords to be placed in a grip channel214.

Turning toFIG.13a left side view of alternative embodiment of body102(without first first protrusion130or second protrusion132shown and after securement strap106is under tension) is shown. In this embodiment securement flanges150and slots144could be configured to be curved, in a “torturous path” type of slot. Such a configuration could prevent line222held in grip channel142from being pulled in a straight direction out of grip channel142and slot144, which is the path of least resistance in the event of a force vector218or220in that direction. Knowing force vectors are typically linear and are being pulled from a constant location and position, a curved flange150and slot144configuration would significantly decrease the likelihood of a line pulling straight through a straight (whether vertical or angled slot). A curved or zig-zag shape of slot144would be a secondary defense against the pulling of line222straight up and out of body102with the “pinching” affect and friction being applied to the line to keep it in place while the line is under tension. If a line pulls through slot144and is under load against securement strap106, it will otherwise have an insignificant load reduction capacity during a significant line pull force. After such line pull incidents, the armband shall be inspected to ensure the lines are back in their proper grip channels.

A method to use securement device100begins first with configuring device100with at least one slot144, at least one flange150, a first termination end114, a second termination end116, and a securement strap106around a securement body with each slot144on securement body102facing up or toward the sky. Next, medical tubes, IV lines, and/cords are inserted into the grip channel142of securement body102that most closely resemble the size of the line diameter (device100is in an open state). Next, securement strap106is fastened and tightened, causing each flange150to touch the neighboring flange150or second termination end116(device100is in a closed position). Also, in the event of a catastrophic or adverse load applied to device100, if and when a line is in this position shown by line222or in any of the embodiments mentioned, fluid flow and drug delivery to the patient via the line will not be altered or compromised as the line is not pinched fully based on the design, shape, size, and materials of device100as described in this application.

While the present invention has been described above in terms of specific embodiments, it is to be understood that the invention is not limited to these disclosed embodiments. Many modifications and other embodiments of the invention will come to mind of those skilled in the art to which this invention pertain, and which are intended to be and are covered by both this disclosure and the appended claims. It is indeed intended that the scope of the invention should be determined by proper interpretation and construction of the appended claims and their legal equivalents, as understood by those of skill in the art relying upon the disclosure in this specification and the attached drawings. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future.