Medical tubing tension relief securement device

Abstract

The present invention relates to an apparatus, system and method for mitigating dislodgement or pullout of each tubing, tube and power cord from the insertion site on a patient of the tubing, tube and power cord attached to a fixed structure such as the patient, when each tubing, tube and power cord can be routinely pulled or yanked accidentally as the patient is moved, handled or treated in a hospital, medical or other environment.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] U.S. Provisional Application No. 63 / 325,671, filed March 31, 2022. Technical Field

[0003] Embodiments of the present disclosure generally relate to medical line strain relief and fixation devices. Background Art

[0004] Clinicians and patients currently do not have tools or products that can prevent lines (including intravenous (IV) lines, cables, power cords, etc.) from being pulled or dislodged from the patient's insertion site when the patient needs to be mobilized. Currently, in the United States, 19 million lines are pulled out each year, and this problem is underestimated. Mobilization includes transporting or moving the patient; bed transfers; including clinician movement around the patient or bed; patient tasks such as sitting up, standing, moving to a chair, walking to the bathroom; or performing rehabilitation therapy. Currently, 64% of early mobility therapy in the intensive care unit (ICU) setting is spent on detangling and securing lines.

[0005] After an invasive procedure or injury, early mobility therapy is one of the best ways to increase healing rates. However, most patients with severe hospitalization have multiple lines and power cords connected to life-saving medical equipment. During early mobility therapy, these connections create real problems and obstacles because patients experience discomfort, pain, and fear of significant injury. Once discomfort is felt, it is human nature not to repeat the same activity. Therefore, if the lines pulled on the line insertion site feel discomfort during treatment, the patient will not want to undergo the treatment again, which may hinder the patient's ability to recover. Or worse, the lines are accidentally pulled out from the patient's insertion site. The lines may include life support lines or diagnostic monitoring equipment required for life support. If the life support lines are pulled out from the insertion site, unless emergency intervention is performed quickly and accurately, the patient may die. Several types of trauma, from mental fear to physical pain to the risk of death, prevent the desire to undergo the required treatment that promotes recovery.

[0006] Strips or adhesives and sutures are common methods for fixing the line to the patient's skin at the patient's insertion site. This has many disadvantages, such as uncomfortable stinging, skin tearing, skin irritation, scarring, and skin infection. Adhesives only provide minimal strength to holding the line, and a pulling force between 4-9 pounds (1.8-4.1 kg) can pull out a typical adhesive. Clinicians have also used adhesive tape and medicine cups or tongue depressors to group the intravenous line and power cord to the bed rails, or have used rolled-up incontinence pads and taped the intravenous line to the pads, and then nailed them to the patient's gown, in order to attempt to fix with limited success with minimal fixation. Line pulling and pulling out are known problems, and the solutions mentioned are the best options, and resource-rich clinicians have begun to try a kind of patient who controls them and provide some kind of safe means for them. There is currently no device available that is reliable, reusable, and secures multiple IV lines, tubes, and power cords in a single location while also providing strain relief for pull forces applied to the lines, tubes, or power cords up to and exceeding at least 9 pounds (4.1 kg) of pull. Summary of the Invention

[0007] An object of the present invention is to provide a device that is inserted between the attachment site of a line, tube or power cord on a patient's body and the source of tension on the line, tube or power cord (such as by pulling or tugging), which prevents each line, tube or power cord from becoming dislodged at the patient attachment or insertion site, as may routinely occur during patient movement, handling or treatment in a hospital or medical environment.

[0008] Another object of the present invention is to provide an apparatus comprising a minimum number of parts that are easy to manufacture.

[0009] According to a first embodiment, the present invention relates to a device comprising an armband, a fixation body attached to the armband, a fixation strap configured to displace the fixation body, and a strap attached to the armband used to secure the armband to a fixed structure (such as a patient, a bed, an IV pole, a crutch, etc.). The fixation body is configured to securely hold at least one line, tube, or power cord, and the strap can additionally secure at least one transducer or another device to the armband. Furthermore, the armband is biocompatible with human skin and can be worn by the patient for at least one day, but preferably up to or exceeding 30 days.

[0010] According to the second embodiment, the fixing body may fix a single pipeline or a plurality of pipelines within the single fixing body, and furthermore, the fixing strip and the fixing body may be formed integrally with each other.

[0011] According to a third embodiment, the fixation body may be of a reduced shape and material composition designed to provide a specific amount of pulling force, such as 9 pounds (4.1 kg) or 20 pounds (9.1 kg) or even 70 pounds (31.8 kg) or more.

[0012] The present invention also relates to a method for mitigating the unwanted removal of lines, tubes, and power cords attached to a patient, starting with a fixture having a securing strip, at least one clamping channel, and at least one flange, wherein the flange extends around a securing structure, such as a patient's arm, toward the top of the fixture body with the flange and slot of the fixture facing upward. Next, the lines, tubes, and power cords attached to the patient at the patient's insertion site are each attached to the fixture. Finally, the fixture body is placed under compression so that each flange contacts an adjacent flange and each slot width is reduced, thereby securing the fixture to each line, tube, and power cord so that if any of the secured lines, tubes, or power cords are yanked or pulled, each line, tube, and power cord inserted into the patient will remain in place, unaffected, at their insertion site because the pulling force from the yanking or pulling is mitigated by the device. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is an enlarged rear perspective view of an embodiment of the present invention;

[0014] Figure 2 is a front exploded view of an embodiment of the present invention;

[0015] Figure 3 is a perspective view of a fully assembled embodiment of the present invention;

[0016] Figure 4 is a front perspective view of an embodiment of the present invention;

[0017] Figure 5 is a perspective view of an embodiment of a fixed body 102;

[0018] Figure 6 is a top view of an embodiment of the fixed body 102;

[0019] Figure 7A is a left side view of an embodiment of the fixation body 102 of the first and second portions 130, 132, not shown, prior to compression from the fixation strip 106;

[0020] Figure 7B is a left side view of an embodiment of the fixation body 102 with the first portion 130 and the second portion 132 (not shown) after being compressed from the fixation strip 106;

[0021] Figure 8 is a front perspective view of an alternative embodiment of the present invention with transducer 158 attached;

[0022] Figure 9 is a perspective view of an alternative embodiment of the present invention attached to a patient;

[0023] Figure 10 is a perspective view of an alternative embodiment of the present invention attached to a patient;

[0024] Figure 11 is a perspective view of an alternative embodiment of the present invention secured to a stationary object;

[0025] Figure 12A is a perspective view of another alternative embodiment of the present invention in an open position;

[0026] Figure 13 B is a perspective view of another alternative embodiment of the present invention in a closed position;

[0027] Figure 13 is a left side view of an alternative embodiment of body 102. DETAILED DESCRIPTION

[0028] For the terms defined below, these definitions will be applied, unless different definitions are given in the claims or elsewhere in this specification. Regardless of whether it is explicitly stated, it is assumed in this article that all numerical values ​​are modified by the term "about". In the context of numerical values, the term "about" generally refers to a numerical range (for example, having the same function or result) that a person skilled in the art would consider to be equivalent to the value listed. In many cases, the term "about" can include numbers rounded to the nearest significant figure. Unless otherwise indicated, the other uses of the term "about" (for example, in the context other than numerical value) can be assumed to have their common and conventional definitions, as understood and consistent with the context of the specification.

[0029] For the following defined terms, these definitions will apply unless a different definition is given in the claims or elsewhere in this specification. Although some suitable sizes, ranges and / or values ​​are disclosed for various components, features and / or specifications, those skilled in the art in light of this disclosure will understand that the desired sizes, ranges and / or values ​​may deviate from those explicitly disclosed.

[0030] 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 used in their sense including "and / or" unless the content clearly dictates otherwise. It should be noted that for ease of understanding, certain features of the present disclosure may be described in the singular, even though those features may be plural or repeated in the disclosed embodiments. Unless explicitly stated to the contrary, every example of a feature may include and / or be encompassed by the singular disclosure.

[0031] As used herein, the terms "line," "tube," "intravenous," and "power line" are intended to be interchangeable and refer to any flexible, medical-grade material used to carry fluids, gases, information, or electricity.

[0032] Now refer to Figures 1-13 A medical tubing strain relief fixation device, system and method are described. Turning to the drawings, wherein reference numerals indicate corresponding elements throughout the several views, attention is first drawn to Figure 1 , which shows an enlarged rear perspective view of an embodiment of the present invention, illustrating its components, generally designated by reference numeral 100. The medical line strain relief fixture 100 is designed to eliminate dangerous pulling and displacement of tubing or power cords from the patient during treatment, transport, and patient movement. Fixture 100 can be single-use or reusable, with the current embodiment tested to operate effectively for up to 30 days. Fixture 100 is configured to secure and organize one or more medical tubes, tubing, and power cords of varying sizes and types along the X, Y, and Z axes, resisting tensile forces along these axes. Fixture 100 is also designed to include a minimal set of components, making it easy to manufacture and providing a much-needed solution to the recognized clinical problem of unwanted removal of tubing or power cords from the patient insertion site, potentially leading to equipment failure, patient pain, and in some cases, death. The simplicity and optimization of fixture 100 are the result of over 30 design iterations and thousands of hours of effort. The securing device 100 includes a line securing body 102 comprising a cohesive elastomeric material adhered to a flexible securing band 104, such as an armband (which will be used to refer to element 104, however it should be noted that the armband 104 is not limited to securing around a patient's arm). In a preferred embodiment, the line securing body 102 is permanently attached to the armband 104 (such as by molding, gluing, or The fixing device 100 further includes a fixing strap 106 wrapped around the fixing body 102, wherein the fixing strap 106 is configured to provide a variable amount of tension to the fixing body 102 while also preventing the power cord or line held by the fixing body 102 from moving or being pulled out of the fixing body (see Figure 10 ). In addition, the fixing device 100 further includes a strap 118 that extends through the fixing body 102 and includes a first end 108 configured to be removably connected to the armband 104 so as to tighten and secure the armband 104 around the user's arm or other fixed structure, and the strap 118 also includes a second end 110 configured to be secured to the armband 104. The second end 110 can also be configured to attach at least one transducer (see Figure 8 and Figure 9 ) and preferably three transducers are fixed to the armband 104.

[0033] The armband 104 comfortably wraps around a fixed structure, such as an appendage of the patient, such as an arm or leg, much like a blood pressure cuff, and without adhesive. It should be noted that the fixation device 100 via the armband 104 can be configured by slightly modifying the shape of the fixed body 102 to be mounted to the patient rather than through the arm or leg, such as in cases with ECMO tubing, femoral artery catheters, pulmonary artery (Swan Ganz), oncology, childbirth, respiratory tubes, life flight, neonatal ICU (NICU), military, or other desired situations for line tension relief. The armband 104 can 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. The strap 118 is used to tighten and secure the armband 104 around the arm or other fixed structure. The strap 118 must be properly secured to the armband 104 with appropriate tension to prevent the armband 104 from moving along the fixed structure (such as the patient's arm), which may also require different tension for each patient. It is contemplated that the length and width of the armband 104 may be varied to accommodate specific patient characteristics, such as bariatric, pediatric, or neonatal patients.

[0034] Steering Figure 2 and Figure 3, which shows a front exploded view of an embodiment of the present invention and a perspective view of a fully assembled embodiment of the present invention. The armband 104 further includes at least an upper layer 120 having a body aperture 124 formed therethrough, the body aperture 124 being configured to allow a portion of the fixed body 102 to extend therethrough, wherein a portion of the body 102 (the base 112, the first portion 130, and the second portion 132, as described below) is retained below the upper layer 120, and the lower layer 122 is positioned below the upper layer 120 and the fixed body 102, and an adhesive is positioned between the upper layer 120 and the lower layer 122 (and the portion of the fixed body 102 between the upper layer 120 and the lower layer 122) to bond the layers to the body 102 (preferably permanently), thereby securely clamping the fixed body 102 (via the first portion 130 and the second portion 132, as described below) to the armband 104. The body hole 124 is shaped to be free of the perimeter of the fixing body 102 along the X-axis and Y-axis (in the XY plane) (the perimeter of the flange 150, the first end 114, and the second end 116 described below) of the base 112, and the body hole 124 is a rectangle with rounded corners, wherein the longest side is curved. The body hole 124 is oriented so that its longest side extends across the width (X-axis) of the armband 104, but the hole 124 can be positioned in alternative locations and positions on the armband 104 if it is desired to operate with the fixing body 102. The upper layer 120 includes foam (or other flexible material, such as fabric, plastic, etc.) having a top surface 134, wherein the top surface 134 is covered with a material such as The top surface 134 also includes artwork 140 printed on, embossed with, or otherwise made visible on the top surface 134 of the upper layer 120 to indicate the proper orientation of the device 100 when secured to the patient. The orientation of the fixation body 102 is important for optimizing tube or power cord securement during a pull because the orientation of the fixation body 102 contributes to the ability of the fixation device 100 to prevent the power cord or cable from pulling out from all directions (described in more detail below). In the current embodiment, the artwork 140 includes the text "UP" with an arrow graphic located near one edge of the top surface of the upper layer 120 to indicate that the device 100 should be oriented so that the artwork 140 is located closest to the patient's head or the top of the fixation body and facing in the direction of the patient's head or the top of the fixation body. This orientation is consistent with the orientation of the fixation body flange 150 and the corresponding slot 144 (discussed below). The armband 104 further includes at least one score mark 164, but preferably a plurality of score marks, spanning the width of the upper layer 120 and the lower layer 122 and positioned in different locations along the length of the upper layer 120 and the lower layer 122 and configured to allow the armband 104 to be flexible so as to be easily wrapped around a fixed structure and secured.

[0035] The lower layer 122 preferably comprises a USP Class VI medical grade and skin biocompatible material that is configured to reduce or eliminate pressure sores that may develop on a patient due to prolonged wear of the device 100 and to provide a non-absorbent barrier to sweat and moisture. To apply the armband 104 to the patient, the armband 104 is applied around the patient's arm in direct contact with the skin without being applied over clothing. The lower layer 122 may also comprise foam (or other comfortable, flexible material) and be configured to provide a useful amount of friction so as not to slide freely along the surface of the skin (similar to the tension provided by a flexible neoprene knee brace to stay in place) and not require over-tightening or re-tightening to stay in place. In the current embodiment, the armband 104 (via the upper layer 120 and the lower layer 122) is approximately 17.75 inches (450.85 mm) long along the Y-axis and 4 inches (101.6 mm) wide along the X-axis, with score marks 164 located approximately every 1 inch (25.4 mm) along the length of the armband 104, and with the center of the body hole 124 located approximately 2 inches (50.8 mm) from one longitudinal end of the armband 104.

[0036] The strip 118 preferably includes on at least one side 1. Hook fastener material, wherein the first end 108 is wider along the X-axis (approximately 1.88 inches (47.75 mm)) and longer along the Y-axis (approximately 3 inches (76.2 mm)) than the second end 110, which is approximately 0.75 inches (19.1 mm) wider along the X-axis and 2.75 inches (69.9 mm) long along the Y-axis, to provide a larger surface area for adhering the hook fastener material of the strip 118 to the top surface 134 of the upper layer 120, although the dimensions of the first end 108 and the second end 110 may be varied if desired. The hook fastener material of the strip 118 faces the top surface 134 of the armband 104 to ensure removable attachment of the strip 118 to the armband 104. The strap 118 further includes a middle portion 152 located between the first end 108 and the second end 110 and having a length (along the X-axis) and a width (along the Y-axis) that are less than the length and width of the strap aperture 148 of the fixed body 102 (described below), however, other dimensions may be used as desired. In a preferred embodiment, the middle portion 152 is wider than the first end 108, but may have the same width as the first end 108 if preferred.

[0037] Steering Figure 4, which shows a front view of an embodiment of the present invention. The pipe securing body 102 includes a base 112 and at least one securing flange 150. The base 112 has a first end 114 connected to one side of the base 112 and a second end 116 connected to the other side of the base 112. In this embodiment, seven securing flanges are shown. The securing flanges 150 are positioned between (or sandwiched between) the first and second ends 114, 116 and are integrally formed with and extend away from the base 112. Each flange 150 is positioned so as to be aligned relative to one another and relative to the first and second ends 114, 116. The securing body 102 also includes at least one clamping channel 142 formed through the base 112 along the Y-axis and being primarily circular or cylindrical in shape. The at least one clamping channel 142 is configured to retain at least a portion of a pipe, pipeline, or power cord. Other lines and power cords besides IV lines can be inserted into the similarly sized clamping channels 142, such as oxygen tubing for pulse oximetry lines or cables, which are flexible but radially rigid and cannot be squeezed out of shape like hollow fluid lines. These other lines or power cords can have different sizes depending on the aforementioned application. The clamping channels 142 are located between the first end 114 and at least one flange 150, between at least one flange 150 and another flange 150, and between the flange 150 and the second end 116. Each clamping channel 142 is further connected to a slot 144 extending away from the clamping channel 142, wherein the slots 144 are configured to allow a tube, line, or power cord to slide through the slot into the corresponding connected clamping channel 142. Each slot 144 is defined by a flange 150 and another flange 150, a flange 150 and the first end 114, or a flange 150 and the second end 116. The overall shape of the first pipeline securing body 102 is intentionally curved in the XZ plane along the first end 114, each flange 150, and the top of the second end 116 to ensure that the securing body 102 adequately secures the retained pipeline or tube within the clamping channel 142 by applying a force to the retained pipeline or tube around its circumference using the concept of hoop stress (described below). The securing body 102 is also curved in the XY plane (see FIG. Figure 6 ), wherein the flange 150 located at the center point of the body 102 is the longest (along the Y axis), wherein each subsequent flange 150 decreases in length (along the Y axis) toward the first end 114 and the second end 116 to create a tapered effect (partially for at least cosmetic design reasons) (see Figure 6In the present embodiment, the fixed body 102 is symmetrically formed along the XZ plane and the XY plane. In addition, if there is more than one flange 150 attached to the base 112, all flanges 150 can be of varying lengths, preferably symmetrical along the X axis around a central flange 150 that is centrally located on the fixed body 102 and is the tallest compared to the other flanges 150. In the current embodiment, the length (along the X-axis) of the base 112 is approximately 3.13 inches (79.4 mm) and the width tapers from a length of approximately 1.5 inches (38.1 mm) at the center of the base 112 to a width of 1.25 inches (31.8 mm) at the first and second ends 114, 116 (the flange 150 also follows this width range, having a thickness ranging from 0.125 inches (3.18 mm) to approximately 0.25 inches (6.35 mm) and a slot 144 having a length ranging between approximately 0.125 inches (3.18 mm) and 0.75 inches (19.05 mm), however, if desired, these dimensions may be varied for reasons including, but not limited to, varying the number of tubing secured by the securing body 102 (by varying the number of clamping channels 142), varying the force applied to the secured tubing, and varying the diameter of the secured tubing. Each slot 144 is preferably straight (as defined by two adjacent retaining flanges 150, a segment flange 150 and a first end 114, or a flange 150 and a second end 116), but each slot 144 may be curved or variable in shape if desired (see FIG. Figure 13). It is important to note that while the clamping channel 150 is preferably circular or cylindrical (to accommodate at least a portion of a circular or cylindrical tube), it can be other shapes to accommodate flexible tubes of other shapes. The diameter of the clamping channel 150 is specific to a specific range of intravenous line, tube, or power cord diameters to ensure proper and optimal fixation. Although medical tubing and power cords do not follow standard size guidelines, there are similarities between manufacturers that are in a close enough size range that an average nominal tubing size can be determined to be common to tubes, lines, and power cords of sufficiently significant sizes to warrant a value for generating a common clamping channel 142 size to accommodate each range of tubes, lines, and power cords. There is also an infinite range of tubing, tubes, and power cords, but the nominal groupings selected in the current embodiment are approximately 1 / 8" (or close to 3 mm) and approximately *4" (or close to 6 mm). Each clamping channel 142 in the fixation body 102 accommodates the width of the slot 144 required for manufacturability of the fixation body 102 (preferably by injection molding or other molding process) and to allow insertion of a tube that matches the diameter of a particular clamping channel 150, such that when the fixation body 102 is in its restrained state via tensioning the fixation strap 106, the dimensions of the clamping channel 150 are such that each slot 144 is closed or minimized by contact between each flange 150, flange 150, and end 114, or end 116, so that the clamping channel 142 matches this nominal 1 / 8" and 1 / 4" diameter dimension and so contacts the outer surface of the retained tube around its circumference. The secure fit of the tube to the clamping channel 142 is critical because the clamping channel 142 size that most closely matches the tube, line, or power cord will have the greatest impact on limiting line tension (and preventing pullout of the tube in the patient insertion site). It is contemplated that the clamping channel 142 may include other nominal diameter sizes, and that the line securing body 102 may include any desired number of securing flanges 150, and therefore any desired number of clamping channels 142 and slots 144, as desired for a particular application. Similarly, the clamping channel 142 should be as close to a circle as possible in shape to provide a uniform load around the retained tube, thereby exerting a strong grip around the entire retained tube and preventing fluid restriction within the tube. If the clamping channel 142 were oval, square, triangular, or any shape other than circular (assuming a circular tube is retained by the clamping channel 142), the clamping force exerted on a tube retained within the clamping channel 150 would not be uniform around the circumference of the tube and would therefore be weaker than if it were circular.The first end 114 is located on one end of the fixed body 102 (along the X-axis) and is generally curved or partially teardrop-shaped on one side and may also include a flange 150, while the second end 116 is located on the opposite end of the fixed body 102 (also along the X-axis) and is generally curved in a direction opposite to the first end 114 and may include an extension 168 protruding in a direction opposite to the flange 150, wherein the extension 168 helps to form the clamping channel 150 and the groove 144 between the end 116 and the adjacent flange 150.

[0038] If a pull occurs on the tubing (IV, line, tube, or power cord is pulled or yanked) that has been secured to the clamping channel 142 by compression of the body 102 by the securing strap 106, the pull is reduced at the device 100 by directing the pull from the device 100 to a fixed structure (e.g., the patient's arm), thereby leaving the patient's insertion site unaffected. The securing device 100 easily reduces 20+ pounds (9.1 kg) of pull (see further description below), and preferably up to 80+ pounds of pull. To give some context on the importance of reducing at least 20+ pounds (9.1 kg) of pull, a central venous catheter can be pulled out with only between 4-9 pounds (1.8-4.1 kg) of pull. Furthermore, due to the design of the device 100, it does not squeeze, deform, or crimp the tubing, allowing safe fluid flow even under significant clamping conditions.

[0039] The base 112 of the fixing body 102 further includes a strap hole 148 formed therethrough, and the strap hole 148 is configured to allow the strap 118 to extend through the strap hole 148. The strap hole 148 is positioned above the upper layer 120 of the armband 104 to allow the strap 118 to be moved through the strap hole 148 for different needs of the user (such as mounting one or more transducers on the first end of the strap 118 or providing additional length to the armband 104 for fixing purposes). In the current embodiment, the strap hole 148 is approximately 1 inch (25.4 mm) along the X-axis and approximately 1.5 inches (38.1 mm) along the Y-axis, however, the size and configuration of the strap hole 148 can be changed if desired. The strap holes 148 are rectangular with rounded corners and are approximately 0.0625 inches (1.59 mm) high along the Z axis, approximately 1 inch (25.4 mm) along the X axis, and 1.56 inches (39.6 mm) along the Y axis, but can be configured in different shapes and sizes as desired.

[0040] Steering Figure 5 and Figure 6, which shows perspective and top views of an embodiment of the fixing body 102. The fixing body 102 also includes a first protrusion 130 connected to the base 112 and extending away from the base 112 (along the Y-axis) perpendicular to each flange 150 and parallel to each clamping channel 142; and a second protrusion 132 connected to the base 112 and extending away from the base 112 (along the Y-axis) perpendicular to each flange 150 and parallel to each clamping channel 142, wherein the second protrusion 132 is a mirror image of the first protrusion 130 and is located on an opposite wall of the first protrusion 130. Both the first protrusion 130 and the second protrusion 132 are generally rectangular with rounded corners, but can be configured into different shapes and configurations as desired according to other potential methods for optimal coupling to the armband 104. The first and second protrusions 130, 132 are configured to be sandwiched between the upper layer 120 and the lower layer 122 and preferably permanently secure the securing body 102 to the armband 104. The securing of the body 102 to the armband 104 is important and significant to ensure that the device 100 can withstand a 20+ lb (9.1 kg) pull on the securing tube, pipe, or cable within the clamping channel 142 and transmit that pull to the securing body 102 to which the device 100 is attached. Figure 6 As described above, the widths of the flange 150, the first end 114, and the second end 150 may vary, and in the current embodiment, they form a generally curved shape. The bottom of the base 112 is flat (although flexible due to the material from which the securing body 102 is derived) so as to allow simple part measurement during molding / manufacturing for improved quality assurance practices and also to allow easy tool assembly and bonding to the upper and lower layers 120, 122, but the bottom of the base 112 is flexible enough to allow the securing body 102 to deform when placed under tension by the securing strip 106, thereby allowing the flanges 150 to overlap relative to each other (and / or the first and second ends 114, 116), the size of the slot 144 to be reduced, and the clamping channel 142 to press against the portion of the securing tube secured within the clamping channel 142, causing the securing body 102 to become symmetrical or nearly symmetrical in shape along the XZ plane, thereby providing a more uniform hoop stress (a uniform compressive force / load applied around the circumference of the portion of the tube retained within the securing body 102, which provides optimal strain relief from tube tension by the device 100) on the securing tube within the clamping channel 142 (see FIG. 7 b).

[0041] return Figure 2 and Figure 4, the securing strap 106 is constructed of a flexible material having a top surface 154 secured to one end, a bottom surface 156, and a buckle 138. In the current embodiment, the securing strap 106 also includes a hook fastener portion 128 located on the bottom surface 156, the hook fastener portion 128 being located near the end of the strap 106 opposite the buckle 138 and extending approximately 2.5 inches (25.4 mm) toward the buckle 138 (although other dimensions may be used), and a loop fastener portion 146 also extending approximately 6.5 inches (165.1 mm) from the buckle 138 to the loop fastener portion 146 on the bottom surface 156, but may have other shapes as desired. It should be noted that the width of the securing strap 106 is important because the width of the current embodiment is approximately 1 inch (25.4 mm), and it has been found that, with the current dimensional characteristics of the securing body 102, a securing strap 106 width of less than 1 inch (25.4 mm) increases the pressure exerted on the securing tubing in each clamping channel 142 compared to a securing strap 106 width of 1 inch (25.4 mm) at the same tension (approximately 10 pounds (4.5 kg) in the current embodiment), which may be useful in some embodiments. In use, the securing strap 106 is drawn around the securing body 102 in the XZ plane and against the securing body 102, thereby causing the flanges 150 to contact or overlap and the securing body 102 to compress around the tubing contained within each clamping channel 142, thereby preventing the securing tubing from moving within the securing body 102 due to tugging or pulling. The top surface 154 of the securing strap 106 is brought into sliding contact with the securing body 102 along the XZ plane, and the securing strap 106 is passed through the buckle 138 such that the loop fastener portion 146 is in contact with the hook fastener portion 128 at a desired tension, however, it is contemplated that at least a portion of the securing strap 106 may be secured to the securing body 102 or the armband 104. The tension the securing strap 106 applies to the securing body 102 is variable and depends on the length of the securing strap 106 passed through the buckle 138. While other types and brands of materials may be used for the loop fastener portion 146 and the hook fastener portion 128, Brand is preferred. In addition, the securing strap 106 can be maintained to slide between the bottom of the base 112 and the lower layer 122 of the armband 104 to allow variable tension to be applied to the body 102. The securing strap 106 desirably includes However, other methods of securing the straps known in the art may be used, such as zippers, cords, clips, hooks or elastomeric closure straps, and the like.

[0042] During pull testing of pipelines, tubes, and power cords secured within the fixture 100, it was discovered that the orientation of each slot 144 (and therefore each flange 150), which allows for insertion or removal of each pipeline, produced slight changes in the fixture body 102 when a pull force was applied in the same direction and alignment as the slot 144, even when the fixture body 102 was compressed by the fixture strap 106. Therefore, because patients and their arms are statistically upright while sitting, standing, and during treatment, each slot 144 and fixture flange 150 is configured to face upward, toward the top of the arm (or the person's head), when the device 100 is secured to the patient, in order to reduce the likelihood of tension on the pipelines secured in the device 100 in the direction of the slot 144, as most pipeline tension is directed downward (toward the floor) due to gravity. Thus, each slot 144 is oriented in the least likely direction for pipeline traction to occur with maximum pipeline securement. Furthermore, the angle of each retaining flange 150 (and therefore each slot 144) allows each retaining flange 150 to overlap with an adjacent retaining flange 150 or second end 116 (and allows the first end 114 to overlap with an adjacent flange 150) and provide a compressive load on any IV line, tube, or power cord within each clamping channel 142 when the retaining strap 106 is tightened downwardly (e.g., a strap force of 10 pounds (4.5 kg) may be sufficient to provide at least 20 pounds (9.1 kg) of tension relief on the line or tube secured within the clamping channel 142), rather than potential buckling of the line, tube, or power cord if each retaining flange 150 (and therefore each slot 144) were oriented purely vertically (or perpendicular to the base 112).

[0043] Steering Figure 7A and Figure 7B , shows a left side view of an embodiment of the fixation body 102 without the first portion 130 and the second portion 132 before compression from the fixation strap 106 and after compression by the fixation strap 106 (not shown). After multiple tests, the preferred angle of the fixation flanges 150 allows for ease of cord insertion, cord removal, and maximum cord retention, as the flanges 150 uniformly overlap each other to secure the tubing within each clamping channel 142 at loads between 20 and 50 degrees without straining the fixation strap 106, and transmit the compressive load through the body at approximately 35 degrees (relative to the base 112) when the fixation strap 106 is strained and a compressive load is applied to any intravenous line, tube, or power cord within each clamping channel 150. It is contemplated that the angle of each fixation flange 150 may vary depending on the degree of security desired, the common direction of the tension generated, the material of the tubing fixation body, and the diameter size of the clamping channel.

[0044] The fixture 100 is a resilient system that utilizes tensioning forces by means of a securing strap 106 surrounding the fixture body 102. The securing strap 106 distorts the fixture body 102, thereby compressing the IV line with a high degree of force without pinching or otherwise disrupting fluid flow within the flexible tubing. The compressive load generated by the securing strap 106 is applied to the IV line within the clamping channel 150 at simulated or infinitely adjustable tension levels between an open and closed state. Furthermore, as described above, the first and second ends 114, 116 sandwich the securing flange 150, wherein the first and second ends 114, 116, and flange 150 are all positioned in line with one another and configured in a curved shape. This type of shape, while having decorative and aesthetic properties, also allows the fixture body 102 to securely clamp onto IV lines, tubes, and power cords. This type of shape serves to carry and transmit the load (pulling or yanking of the IV line, tube, and power cord) held in each clamping channel 142 in a more uniform manner by clamping more surface area of ​​the line, tube, and power cord being held. When the securing strip 106 is tightened to cause compression of the securing body 102 to surround and clamp the IV line, tube, or power cord (in the clamping channels 150), the securing body 102 shifts significantly to an equilibrium shape, thereby providing equal force around each clamping channel to each line secured in each clamping channel 150. The securing strip 106 closes off each slot 144 between each flange 150, the first end 114, and the second end 116 that were initially used to mount the line into the clamping channels 142, causing the line securing body 102 to become a more uniform oval shape (see FIG. 1 ). Figure 7B). This elliptical shape then transmits the force of the fixation strip 106 to the intravenous line, tube or power cord through a physical phenomenon known as hoop stress. In the embodiments herein, a cylindrical or circular shape of the body 102 would be theoretically ideally balanced and provide the highest amount of strength on all lines (depending on the width of the slot 144 to allow insertion of the line), but would be uncomfortable for the patient and would make for a large and awkward device to attach based on its size or height from the armband 104. In situations where the maximum amount of fixation is desired and the device 100 is not necessarily flush with the patient's arm, a toroidal shape of the fixation body 102 may be desired for maximum ability to resist pulling forces. Thus, the curved or modified semicircular shape of the fixation body 102 in combination with the armband 104 provides an optimal balance of manufacturability, weight, size, performance and patient comfort for the fixation of lines, tubes and power cords. Alternatively, it is contemplated that the curvature of the curve in at least the aforementioned XZ plane may be varied as desired. The greater the amount of flexure of the flange 150, first end 114, and second end 116 of the securing body 102 when in their secured and compressed state (with the securing strap 106 tensioned and the securing flanges 150 overlapping one another), the greater the amount of resistance that can be transferred to the secured IV line, tubing, or power cord within the clamping channel 150 in the event of line pull.

[0045] When the fixation body 102 is a viscous elastomeric material, the key is to balance the ease of tube insertion, patient safety and comfort, and the strength of the device 100 to maintain compression on the inserted tube to prevent the inserted tube from moving within the fixation body 102 through a tensile force of up to at least 9 pounds (4.1 kg), but preferably 20 pounds (9.1 kg). The material properties of the fixation body 102 can be changed if desired for different applications. For example, in life flight or military applications where additional fixation is required, the shape can be changed to provide a greater overall grip on the inserted tube, or the hardness of the material of the fixation body 102 can be changed to increase the grip strength around the clamped tubing at the expense of ease of installation. In a preferred embodiment, the device 100 can withstand a tensile force of at least 20 pounds (9.1 kg) in any direction (along the X, Y, or Z axes) between all tubings held by the device, but preferably up to 80 pounds (36.3 kg) or more (assuming a force of approximately 10 pounds (4.5 kg) is used to secure the securing strap 106 around the body 102). That is, the device will alleviate a force of 20 pounds (9.1 kg) applied to one tubing secured in the clamping channel 142 or a force of 5 pounds (2.3 kg) applied to each of the four tubings secured in the four clamping channels 142. The device's ability to withstand a tensile force of 20 pounds (9.1 kg) or more is a substantial improvement over any current solution and has been a long-standing problem to be solved. However, it is important to note that the amount of relief that can be achieved by the tensioning device 100 depends on a number of factors, including but not limited to the tension of the securing strap 106 applied to the securing body 102, the diameter of the power cords, pipes, and tubes secured within the clamping channel 142, and whether the pipes, tubes, and power cords are rigid / hard or flexible / pliable. Additionally, the direction vector of the tension applied to the pipes, tubes, and power cords and the rate at which the tension is applied can be factors.

[0046] Steering Figure 8 and Figure 9, shows a front perspective view of an alternative embodiment of the present invention in which a transducer 158 is attached to the upper layer 120 of the armband 104 via the first end 108 of the strap 118 and a perspective view of the alternative embodiment of the present invention is attached to the patient. The transducer 158 further includes a base 160 having at least one transducer aperture 162 located on at least one side of the transducer base 160, the at least one transducer aperture 162 being configured to allow the first end 108 of the strap 118 to pass through the at least one transducer aperture 162, thereby securing the transducer 158 to the upper layer 120 via a hook fastener at the first end 108, the hook fastener being attached to a loop fastener on the top surface 134 of the upper layer 120 of the armband 104. The first end 108 of the strap 118 is currently configured to secure up to three transducers 158 in line with one another to the armband 104, however the first end 108 may be made longer or shorter to accommodate a different number of transducers 158 or other desired devices to be secured to the fixture 100. Figure 11 The positioning and location of the first end 108 of the strap 118 is important for transducer use because each transducer 158 is placed on the patient via the armband 104. The device 100 allows for proper positioning of the transducer 158 so that it is aligned or level with the right atrium of the patient's heart 230 (see dashed line), which is crucial for proper monitoring of life-support medications via the transducer 158 based on real-time blood pressure readings. Transducers are designed to be placed on an IV pole, but are more commonly attached to the patient's gown with a clothespin, strapped to their arm, or through the use of products designed to hold a catheter in place in the patient's leg, which unfortunately, regularly falls out of the patient's arm, resulting in unnecessary, potentially life-threatening interruptions. None of these methods can adequately secure the transducer in the correct position mentioned above via the device 100, which is crucial for proper hemodynamic monitoring after procedures such as open heart surgery or transplantation.

[0047] Steering Figure 10 and Figure 11 , shows a perspective view of an alternative embodiment of the present invention connected to a patient and secured to a stationary object. Ultimately, the medical line strain relief fixture 100 is a tension relief or strain relief device and system in which the device transfers tension in the intravenous line from a force vector (e.g., a tug or pull) to the device 100 on the patient's arm, rather than to the intravenous line insertion site into the patient, thereby providing the unique ability to prevent painful line pulling and dangerous displacement at the patient insertion site. Figure 10An example of this is illustrated in FIG, where the device 100 divides at least one line 222 (in the current embodiment, four lines) attached to a patient into a load side 224 and a securement side 226. When the line on the load side 224 of the device 100 is subjected to a force vector (such as a pull), the device 100 absorbs and transfers the force vector to the patient's arm, rather than transferring it to the securement side 226 of the line, which is connected to the patient's insertion site (the location where the line is attached to or extends into the patient's skin or body), thereby potentially preventing pain and injury to the patient from the force vector. When the securement line 222 is not under load, the securement device 100 still continuously applies a compressive clamping force to the line 222, which the patient does not feel. That is, a compressive load via the securement strap 106 is continuously applied to hold the IV line 222 in place via the securement body 102, and this compressive load is independent of the armband 104 surrounding the patient's arm, thereby ensuring that the device 100 is always prepared to prevent pulling or yanking. That is, the compressive load on the body 102 is independent of (and can be independently adjusted for) the force used to tighten the armband 104 around the patient's arm. The compressive load on the fixation body 102 from the fixation strap 106 forces the fixation body 102 into an elliptical shape, which promotes an even distribution of the compressive load on any fixed lines 222 around the circumference of each line 222, ensuring a firm grip on each line 222. However, when external tension or pulling force is applied to the lines 222 fixed within the body 102, that load is transferred to the fixation body 102, thereby imposing a compressive load on the lines, which is transferred to the armband 104, which is then transferred to the patient's arm (or other fixed structure). Go to Figure 11 , the device 100 is secured via an armband 104 around a pole (such as an IV pole).

[0048] Steering Figure 12A and Figure 12B, which show perspective views of another alternative embodiment of the present invention in open and closed (or compressed) positions. In this alternative embodiment, the armband 104 can include one or more separate securing bodies 200 that are secured to the armband 104 in the same manner as the securing body 102 (via sandwiching first and second protrusions (not shown) located on a base 212 of the body 200 between the upper layer 120 and the lower layer 122 of the armband 104). The securing body 200 includes a base 212 having a securing strap 202 integrally formed with the securing body 200 (replacing the securing strap 106 of the previous embodiment), a single securing flange 204 forming a clamping channel 214 and a slot 216, and a single end 206, wherein the securing strap 202, the securing flange 204, and the end 206 are all connected to the base 212. The end 206 further includes a protrusion 208 extending away from the securing flange 204. The securing strap 202 further includes at least one opening 210 formed therethrough, configured to secure over a protrusion 208, which is essentially a hook-like feature for retaining over the opening 210. Different tensions can be applied to the securing body 200 by securing different openings 210, wherein openings 210 formed closer to where the securing strap 202 connects to the base 212 will produce greater tension on the securing body 200, and openings 210 formed in the securing strap 202 further from the base 212 will produce less tension on the securing body 202. Such an embodiment allows for the removal or adjustment of a single tubing within a particular securing body 200 without affecting the tension of any adjacent securing bodies 200 or the tubing they secure, if multiple securing bodies 200 are located on a single armband 104. In the open position, tubing can be placed into the clamping channel 214 via the slot 216. In the closed position, the tubing is secured in the clamping channel 214 when the securement strip 202 overlaps the securement flange and distal end 206, thereby positioning the opening 210 of the strip 202 over the tab 208 of the distal end 206, thereby providing tension on the securement body 200 and any retained tubing in the clamping channel 214. Furthermore, in any embodiment, it is contemplated that the width of each slot 216 of the securement body 202 may be increased or modified in conjunction with modifications to the shape or material selection of the body 202 to allow for easier insertion of an intravenous line, tube, or power cord to be placed in the clamping channel 214.

[0049] Steering Figure 13, shows a left side view of an alternative embodiment of the body 102 (not showing the first or second protrusions 130, 132 and after the securing strap 106 is under tension). In this embodiment, the securing flange 150 and slot 144 can be configured to curve in a "zigzag path" style. This configuration prevents the tubing 222 retained in the clamping channel 142 from being pulled out of the clamping channel 142 and slot 144 in a straight direction, which is the path of least resistance given the force vector 218 or force vector 220 in that direction. Knowing that force vectors are generally linear and pulled from a constant position and location, the curved flange 150 and slot 144 configuration significantly reduces the likelihood of the tubing being pulled straight through a straight line (whether vertical or angled). The curved or zigzag shape of the slot 144 provides a secondary defense against the tubing 222 being pulled straight up out of the body 102, with a "squeeze" effect and friction applied to the tubing to hold it in place while it is under tension. If the pipeline is pulled through the slot 144 and is under load against the securing strap 106, it will have insignificant load reduction capabilities during significant pipeline pulls. After such a pulling event, the arm strap should be inspected to ensure the pipeline is returned to its proper gripping channel.

[0050] The method of using the fixation device 100 begins by configuring the device 100 with at least one slot 144, at least one flange 150, a first end 114, a second end 116, and a fixation strap 106 surrounding the fixation body, wherein each slot 144 on the fixation body 102 faces upward or toward the sky. Next, a medical catheter, intravenous line, and / or power cord is inserted into the clamping channel 142 of the fixation body 102 that is most similar in size to the diameter of the tubing (the device 100 is in the open position). Next, the fixation strap 106 is tightened and pulled so that each flange 150 contacts the adjacent flange 150 or second end 116 (the device 100 is in the closed position). Moreover, in the event of a catastrophic or adverse load applied to the device 100, if and when the tubing is in this position shown by tubing 222 or in any of the embodiments mentioned, fluid flow and drug delivery to the patient via the tubing will not be altered or compromised because the tubing is not fully compressed based on the design, shape, size and materials of the device 100 as described in this application.

[0051] Although the present invention has been described above with respect to specific embodiments, it should be understood that the invention is not limited to the disclosed embodiments. Many modifications and other embodiments of the invention will occur to those skilled in the art to which the invention pertains, and these modifications and other embodiments are intended to be covered by and will be covered by the present disclosure and the appended claims. Indeed, 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 skilled in the art in light of the disclosure in this specification and the drawings. Similarly, where this document refers to technology that is obvious or known to one of ordinary skill in the art, such technology includes technology that is obvious or known to one of ordinary skill in the art now or at any time in the future.

Claims

1. A fixing device comprising: Fixing strap; a securing body comprising a top surface and a bottom surface, wherein the securing body is attached to the securing strap and is configured to secure at least a portion of at least one pipe, pipeline, or power cord; as well as a securing strap in contact with the top and bottom surfaces of the securing body, wherein the securing strap applies increasing levels of tension to the securing body as the securing strap is tightened around the securing body, wherein the top surface and the bottom surface are parallel to the length of the portion of the at least one pipe, pipeline or power cord, and the fixing body deforms when the fixing body is under tension from the fixing strap to provide a compressive load to the portion of the at least one pipe, pipeline or power cord, thereby fixing the portion from moving due to tension.

2. The device according to claim 1, wherein The fixation body is configured to provide a nearly uniform compressive load around the circumference of the portion of the at least one pipeline, pipe or power line that is fixed when under tension.

3. The device according to claim 1, wherein The fixing body is configured, when under tension, for absorbing forces applied to the fixed portion of the at least one pipeline, pipe or power cord and for transmitting the forces applied to the fixed portion of the at least one pipeline, pipe or power cord to the fixing strap.

4. The device according to claim 1, wherein The securing device further includes a strap extending through the securing body.

5. The device according to claim 1, wherein The fixing strap further includes an upper layer and a lower layer, the upper layer having a hole formed therethrough, wherein a portion of the fixing body is fixed between the upper layer and the lower layer, and the fixing strap is slidable along the bottom surface of the fixing body.

6. The device according to claim 5, wherein The fixing body extends partially through the hole in the upper layer.

7. The device according to claim 5, wherein The lower layer is composed of USP Class VI medical grade material.

8. The device according to claim 1, wherein The fixing strip is configured to surround the fixing body along a plane.

9. A fixing device comprising: Fixing strap; a securing body attached to the securing band, the securing body further comprising at least one clamping channel formed therethrough, the at least one clamping channel configured to retain at least one tube, line, or power cord; a securing strap positioned about the securing body and configured to apply increasing levels of tension to the securing body as the securing strap is tightened, Wherein, when under tension, the fixing body deforms to generate a nearly uniform circumferential stress around the at least one clamping channel to prevent at least a portion of the at least one tube, pipeline or power cord held by the fixing body from moving within the fixing body due to one or more tensile forces of at least 4.1 kg.

10. The device according to claim 9, wherein The fixed body further comprises: single base; a strap aperture formed therethrough in the base and configured to operate with a strap; at least one flange connected to the base and the at least one clamping channel; and At least one end, Wherein, the at least one flange and the second flange or the at least one end define a slot connected to the at least one clamping channel.

11. The device according to claim 10, wherein The at least one flange is angled between 20 and 50 degrees relative to the base.

12. The device according to claim 10, wherein The fixed body further comprises: a first protrusion extending from the base; and a second protrusion extending from the base, The first protrusion and the second protrusion are configured to attach the fixing body to the fixing belt.

13. The device according to claim 10, wherein One end of the strap is configured to secure at least one transducer to the securing strap and extends through the strap aperture.

14. The device according to claim 13, wherein The strap is further configured to maintain the at least one transducer in alignment with the patient's heart when the strap is secured to the patient's arm.

15. The device according to claim 9, wherein The fixing body is made of a viscous elastic body.

16. The fixing device according to claim 9, wherein The securing device further includes a strap attached to the securing strap and configured to secure the securing strap around a securing structure.

17. The fixing device according to claim 9, wherein: The fixing belt is in communication with a surface of the fixing body.

18. A method for securing a pipe, pipeline or power line to a fixture, the method comprising: A fixing band comprising a fixing strip and a fixing body is fixed to a fixing structure, the fixing body having at least one clamping channel, wherein each clamping channel is defined by two flanges or one flange and one end, wherein the two flanges or the one flange and the one end each further include a top surface; at least a portion of the pipe, pipeline or power cord is inserted into the at least one clamping channel; and the fixing band is tightened around the fixing body so that the fixing band contacts each top surface of the two flanges or the one flange and the one end, thereby causing the fixing body to deform to generate hoop stress around the at least one clamping channel, the hoop stress preventing the at least a portion of the pipe, pipeline or power cord from moving.

19. The method according to claim 18, wherein The diameter of the at least one clamping channel closely matches the outer diameter of the tube, pipeline or power cord.

20. The method according to claim 18, wherein A portion of the fixing body forming the at least one clamping channel is compressed around the circumference of the pipe, pipeline or power cord.

21. The method according to claim 18, wherein The securing device further comprises a strap.

22. A fixing device comprising: a securing strap configured to be removably attached to a fixed structure by tension; a securing body attached to the securing strap and configured to secure at least one pipeline, tube, or power cord, the securing body being attached to the securing strap and further comprising a surface; and a fixing strip surrounding the fixing body and in contact with the surface, Wherein, the fixing body is configured to separate the at least one pipeline, tube or power line into a load side and a fixing side when under the tension of the fixing strip, and the fixing body is configured to transmit one or more tensile forces applied to the load side of the at least one pipeline to the fixing body and the fixing structure rather than to the fixing side of the at least one pipeline, tube or power line.

23. The fixing device according to claim 22, wherein: The securing strap can be tightened and adjusted independently of the securing strip.

24. The fixing device according to claim 22, wherein The fixing strip and the fixing body are made in one piece.

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