Medical Line Strain Relief Fixtures

Abstract

The present invention relates to devices, systems, and methods for mitigating the displacement or withdrawal of lines, tubes, and cords attached to a fixed structure, such as a patient, from their insertion site in the patient when the lines, tubes, and cords are accidentally pulled or tugged, as may occur routinely during patient movement, treatment, or therapy in a hospital, medical environment, or other environment.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) U.S. Provisional Application No. 63 / 325,671, filed March 31, 2022.

[0002] FIELD OF THE DISCLOSURE Embodiments of the present disclosure relate generally to medical line strain relief and securement devices. [Background technology]

[0003] Currently, physicians and patients have no tools or products that can prevent line pulls (lines include IV tubing, cables, cords, etc.) or line dislodgement from the patient's insertion site when a patient needs to be mobilized. Currently, 19 million line pulls occur annually in the United States, and the problem is under-reported. Mobilization includes patient transport or transfer, bed relocation, physician movement around the patient or bed, patient tasks such as getting up, standing, transferring to a chair, walking to the bathroom, or performing rehabilitation therapy. Currently, 64% of early mobilization therapy in the intensive care unit (ICU) environment is used to untie and secure lines.

[0004] After an invasive procedure or trauma, early mobilization therapy is one of the best ways to speed up recovery. However, many critically ill hospitalized patients have multiple lines and cords and are connected to life-saving medical equipment. During early mobilization therapy, these connections create real problems and barriers as patients experience discomfort, pain, and fear of serious trauma. It is human nature not to repeat the same activity if discomfort is felt. Therefore, if discomfort is felt during therapy from line pulling on the line insertion site, the patient may not want to do the therapy again, which may hinder the patient's ability to heal. Even worse, a line may be accidentally pulled out of the patient's insertion site, and the line may contain a life-support line or diagnostic monitoring equipment required to support life. If a life-support line is pulled out of the insertion site, the patient's death may occur unless emergency intervention is performed quickly and accurately. Several types of trauma, from psychological fear to physical pain, to the risk of death, may hinder the desire to perform the therapy required to promote recovery.

[0005] Tape or adhesive and sutured lines are commonly used methods to secure lines to the patient's skin at the patient's insertion site. This has many drawbacks, including bothersome discomfort, skin tears, skin irritation, plaque, and skin infection. Adhesives provide a minimal amount of strength to grip the line, and a pulling force of between 4-9 lbs. can pull off a typical adhesive. Physicians have also used tape and medication cups or tongue depressors to gather IV lines and cords to bed rails, or have used rolled incontinence pads and taped the IV lines to the pads and then secured them to the patient's clothing, but these attempts have provided minimal fixation and have not been very successful. Line pulling and pull-out are known problems, and the solutions mentioned are the best that resourceful physicians have come up with in an attempt to find a means to control and provide some safety to the patient. Currently, there is nothing available that is reliable and reusable to secure multiple IV lines, tubing, and cords in one place while also providing strain relief for up to at least 9 lbs. of pulling force applied to the lines, tubing, or cords and up to and including 4.1 kg (9 lbs.). Summary of the Invention [Problem to be solved by the invention]

[0006] It is an object of the present invention to provide a device that is inserted between the attachment site of a line, tube, or cord on a patient's body and the origin of a pulling force (such as a drag or pull) on the line, tube, or cord, which prevents displacement of the line, tube, or cord at the patient's attachment or insertion site, such as may routinely occur during patient transport, treatment, or therapy in a hospital or medical environment.

[0007] Another object of the present invention is to provide an apparatus that is easy to manufacture and has a minimum number of parts. [Means for solving the problem]

[0008] 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, which is utilized to fix the armband to a fixed structure such as a patient, a bed, an IV pole, crutches, etc. The fixation body is configured to hold at least one line, tube, or cord in a fixed manner, and the strap can further fix at least one transducer or another instrument to the armband. Furthermore, the armband is biocompatible with human skin and can be worn by a patient for at least one day, but preferably up to 30 days or more.

[0009] According to a second embodiment, the fastener may fasten a single line or multiple lines within a single fastener, and furthermore the fastening strap and the fastener may be integrally formed with each other.

[0010] According to a third embodiment, the fixation body may be of a shape and material composition designed to provide a particular amount of pulling force relief, such as 9 lbs., or 20 lbs., or even 70 lbs. or more.

[0011] The present invention also relates to a method for mitigating undesired removal of lines, tubes, and cords attached to a patient, by first securing a retainer having a retaining strap, at least one gripping passage, and at least one flange, the flange extending toward the top of the retainer around a fixed structure such as the patient's arm, with the flange and groove of the retainer facing upwards. Next, the lines, tubes, and cords attached to the patient at an insertion site on the patient are each attached to the retainer. Finally, the retainer is compressed, causing each flange to contact an adjacent flange and reducing the width of each groove, thereby securing the retainer to each line, tube, and cord, such that even if any of the secured lines, tubes, or cords are pulled or pulled, the pulling force from the pull or pull is mitigated by the device, so that each line, tube, and cord inserted into the patient is not affected and remains in the correct position at the insertion site. [Brief description of the drawings]

[0012] [Figure 1] FIG. 2 is an enlarged rear perspective view of the embodiment of the present invention. [Diagram 2] FIG. 2 is a front exploded view of an embodiment of the present invention. [Diagram 3] FIG. 1 is a perspective view of a fully assembled embodiment of the present invention. [Figure 4] FIG. 1 is a front perspective view of an embodiment of the present invention. [Diagram 5] FIG. 2 is a perspective view of an embodiment of a stationary body 102. [Figure 6] FIG. 2 is a top view of an embodiment of a stationary body 102. [Figure 7A] 1 is a left side view of an embodiment of a fixator 102 prior to compression by fixation straps 106, with first portion 130 and second portion 132 not shown. [Figure 7B] FIG. 1 is a left side view of an embodiment of a fixator 102 after compression by fixation straps 106, with first portion 130 and second portion 132 not shown. [Figure 8]FIG. 13 is a front perspective view of an alternative embodiment of the present invention with a transducer 158 mounted thereon. [Figure 9] FIG. 1 is a perspective view of an alternative embodiment of the present invention connected to a patient. [Figure 10] FIG. 1 is a perspective view of an alternative embodiment of the present invention connected to a patient. [Figure 11] FIG. 13 is a perspective view of an alternative embodiment of the present invention secured to a stationary object. [Figure 12A] FIG. 13 is a perspective view of another alternative embodiment of the present invention in an open position. [Figure 13B] FIG. 13 is a perspective view of another alternative embodiment of the present invention in a closed position. [Figure 13] FIG. 2 is a left side view of an alternative embodiment of the stationary body 102. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] For the terms defined below, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification. In this specification, all numerical values, whether expressly stated or not, are considered to be modified by the term "about". The term "about" in the context of numerical values ​​generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in non-numerical contexts) may be considered to have the ordinary and customary definition as understood from and consistent with the context of this specification, unless otherwise specified.

[0014] For the terms defined below, these definitions shall be applied unless a different definition is given in the claims or elsewhere in this specification. Although certain suitable dimensions, ranges, and / or values ​​are disclosed for various components, features, and / or details, one of ordinary skill in the art will recognize that the dimensions, ranges, and / or values ​​suggested or desired by this disclosure may deviate from those specifically disclosed.

[0015] As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used herein and in the appended claims, the terms "and" and "or" are generally used in the sense including "and / or" unless the context clearly dictates otherwise. For ease of understanding, it should be noted that certain features of the present disclosure may be described in the singular even though the feature may be multiple or repeated in a disclosed embodiment. Each instance of a feature may include or be encompassed by the singular disclosure unless specifically stated otherwise.

[0016] As used herein, the terms "line," "tubing," "IV," and "cord" are intended to be interchangeable and mean any flexible, medical grade material used to transport fluids, gases, information, or electricity.

[0017] With reference to Figures 1-13, a medical line strain relief securement device, system, and method will be described. With reference to the accompanying drawings, where reference numerals indicate corresponding elements throughout the several views, and attention is initially directed to Figure 1, where a rear perspective close-up view illustrating the composition of an embodiment of the present invention is shown, and reference numeral 100 indicates the entire device. The medical line strain relief securement device 100 is designed to eliminate dangerous pulling and dislodging of lines or cords from a patient during therapy, transport, and patient mobility. The securement device 100 may be single use or reusable, and in this embodiment has been tested to operate effectively for up to 30 days. The securement device 100 is configured to secure and organize one or more various sizes and types of medical tubing, lines, and cords along the X, Y, and Z axes against pulling forces along the X, Y, and Z axes. The securement device 100 is also designed to include a minimal set of components that are easily manufacturable and provide a much needed solution to the recognized clinical problem of undesired tube or cord removal from a patient's insertion site, which can cause malfunction of the device to which the tube or cord is attached, patient pain, and even death. The simplicity and optimization of the securement device 100 is the result of over 30 design iterations and thousands of hours of labor. The securement device 100 includes a line securement 102 made of an adhesive elastomeric material affixed to a flexible securement band 104, such as an arm band (note that although this is used to refer to element 104, arm band 104 is not limited to being secured around a patient's arm). In a preferred embodiment, the line securement 102 is permanently attached to the arm band 104 (such as by molding, gluing, Velcro®, suturing, ultrasonic welding, or other methods), but may be removable or may be bonded using known methods for securing two or more dissimilar materials together. The retainer 100 further includes a retainer strap 106 wrapped around the retainer 102 and configured to provide a variable amount of tension to the retainer 102 while preventing a cord or line held by the retainer 102 from moving or being pulled out of the retainer (see FIG. 10).Additionally, the fixation device 100 further includes a strap 118 extending through the fixation body 102 and including a first end 108 configured to be removably coupled to the armband 104 for fastening the armband 104 around a user's arm or other fixed structure, the strap 118 also including a second end 110 configured to be secured to the armband 104. The second end 110 is also configured to secure at least one transducer, preferably three transducers, to the armband 104 (see FIGS. 8 and 9).

[0018] The armband 104 wraps comfortably without adhesive around a fixed structure such as a patient's appendage, such as an arm or leg, just like a blood pressure cuff. It should be noted that the fixation device 100 may be configured to be attached to a patient by other than an arm or leg, such as with ECMO tubing, femoral catheters, Swan Ganz, oncology, labor and delivery, respiratory tubing, life support aviation, neo-natal ICU (NICU), military, or other desirable situations for line strain relief, through clever shape modifications to the fixation body 102 through the armband 104. The armband 104 can also be attached to any conceivable rigid body, such as, but not limited to, an IV pole, or a bed rail, and is intended to move with the patient. A strap 118 is used to tighten and secure the armband 104 around an arm or other fixed structure. The strap 118 must be properly secured to the armband 104 with the proper tension to prevent the armband 104 from moving along a fixed structure such as the patient's arm, and each patient may require different tension. It is contemplated that the length and width of the armband 104 may be varied to accommodate the characteristics of a particular patient, such as an obese, pediatric, or neonatal patient.

[0019] 2 and 3, a front exploded view of an embodiment of the present invention and a perspective view of the embodiment of the present invention fully assembled are shown. The armband 104 further includes at least an upper layer 120 having a body opening 124 formed therethrough and configured to allow a portion of the stationary body 102 to extend through the body opening 124, and a lower layer 122 located below the upper layer 120 and the stationary body 102, with a portion of the stationary body 102 (the base 112, the first portion 130, and the second portion 132 described below) remaining below the upper layer 120, and adhesive located between the upper layer 120 and the lower layer 122 (a portion of the stationary body 102 also located between the upper layer 120 and the lower layer 122) to bond the layers (preferably permanently) to the stationary body 102, thereby fixedly sandwiching the stationary body 102 to the armband 104 (by the first portion 130 and the second portion 132 described below). The body opening 124 is the shape of the periphery of the stationary body 102 along the X-axis and Y-axis (in the XY plane), excluding the first projection 130 or the second projection 132 (described below) of the base 112 (the periphery of the flange 150, the first end 114, and the second end 116, described below), and is a rectangle with rounded corners and a curved long side. The body opening 124 is oriented (X-axis) such that its long side extends across the width of the armband 104, although the opening 124 may be located at other locations and positions on the armband 104 as desired to cooperate with the stationary body 102. The top layer 120 is made of foam (or other flexible material, such as cloth, plastic, etc.) having a top surface 134 that is covered with a loop fastener (not shown), such as Velcro®. The top surface 134 further includes artwork 140 printed, embossed, or otherwise made visible on the top surface 134 of the top layer 120 to indicate the proper orientation of the device 100 when secured to a patient. The orientation of the securement body 102 is important for optimizing securement of a tube or cord when dragged, as the orientation of the securement body 102 contributes to the ability of the securement device 100 to prevent cord or cable pull-out due to dragging from various directions (discussed further below).In this embodiment, the artwork 140 includes the text "UP" accompanied by an arrow graphic and is located near one edge of the top surface of the upper layer 120 to indicate that the artwork 140 is located near the top of the patient's head or fixture and that the device 100 should be oriented to aim in that direction. The orientation coincides with the orientation of the fixture flange 150 and corresponding groove 144 (discussed below). The arm band 104 further includes at least one notch 164, but preferably includes multiple notches 164 located across the width of the upper layer 120 and lower layer 122 and at various locations along the length, configured to allow the arm band 104 to be flexible for easy wrapping and securing around a fixture structure.

[0020] The underlayer 122 is preferably made of a USP Class VI medical grade and skin biocompatible material configured to reduce or eliminate pressure sores that may develop on a patient with prolonged wear of the device 100, and also provides a non-absorbent barrier against sweat and moisture. To apply the armband 104 to a patient, the armband 104 is placed around the patient's arm by direct skin contact rather than through clothing. The underlayer 122 may also be made of foam (or other comfortable flexible material) and is configured to provide a useful amount of friction to prevent it from sliding freely along the surface of the skin (similar to the tension a flexible neoprene knee brace provides to stay in place) and does not require excessive tightening or re-tightening to stay in place. In this embodiment, the armband 104 (composed of the upper layer 120 and the lower layer 122) is approximately 17.75 in. long along the Y axis and 4 in. wide along the X axis, with notches 164 spaced approximately every inch along the length of the armband 104 and the center of the body opening 124 located approximately 2 in. from one longitudinal end of the armband 104.

[0021] The strap 118 preferably includes a Velcro® hook fastener material on at least one side, with the first end 108 being wider (approximately 1.88 in.) along the X-axis and longer (approximately 3 in.) along the Y-axis than the second end 110 (which is approximately 0.75 in. wide along the X-axis and 2.75 in. long along the Y-axis) to provide a larger surface area for adhering the hook fastener material of the strap 118 to the top surface 134 of the top layer 120, although the dimensions of the first end 108 and second end 110 may be varied if desired. The hook fastener material of the strap 118 faces the top surface 134 of the arm band 104, ensuring releasable attachment of the strap 118 to the arm band 104. The strap 118 further includes an intermediate portion 152 located between the first end 108 and the second end 110, and has a length (along the X-axis) and width (along the Y-axis) that are shorter than the length and width of the strap opening 148 (described below) in the fastener 102, although other dimensions may be used as desired. In a preferred embodiment, the intermediate portion 152 is wider than the first end 108, but may be the same width as the first end 108 if preferred.

[0022] 4, a front view of an embodiment of the present invention is shown. The line fixture 102 includes a base 112 having a first end 114 coupled to one side of the base 112 and a second end 116 coupled to the other side of the base 112, and at least one fixture flange 150, seven shown in this embodiment, located between (or sandwiched between) the first end 114 and the second end 116, integrally formed with the base 112 and extending away from the base 112, each flange 150 being aligned with each other and with the first end 114 and the second end 116. The fixture 102 further includes at least one gripping passage 142, formed along a Y-axis through the base 112, generally circular or cylindrical in shape and configured to hold at least a portion of a tube, line, or cord. Other lines and cords other than IV lines, such as hollow fluid lines, flexible but radially rigid and not crushable, oxygen tubing, or electrical cables such as pulse oximetry lines, may be inserted into similarly sized gripping passages 142. These other lines or cords may be different sizes depending on the application as previously mentioned. The gripping passages 142 are located between the first end 114 and at least one flange 150, between the at least one flange 150 and another flange 150, and between the flange 150 and the second end 116. Each gripping passage 142 is further connected to a groove 144 extending away from the gripping passage 142, the groove 144 being configured to allow the tube, line, or cord to slide through the groove and into the corresponding gripping passage 142 connected thereto. Each groove 144 is defined by a flange 150 and another flange 150 , by a flange 150 and a first end 114 , or by a flange 150 and a second end 116 .The overall shape of the first line fixture 102 is intentionally curved in the XZ plane along the tops of the first end 114, each flange 150, and second end 116 to utilize the concept of hoop stress (described below) to ensure that the fixture 102 applies a force to the retained line or tube around the circumference of the retained line or tube, thereby properly securing the tubing within the gripping passage 142. The fixture 102 is also curved in the XY plane (see FIG. 6), with the flange 150 located at the center point of the fixture 102 being the longest (along the Y axis) and each of the succeeding flanges 150 decreasing in length (along the Y axis) toward the first end 114 and second end 116, creating a tapering effect (at least in part for decorative design reasons) (see FIG. 6). In this embodiment, the fixture 102 is symmetrical along the XZ and XY planes. Furthermore, when more than one flange 150 is attached to the base 112, all of the flanges 150 may have different lengths and are preferably symmetrical along the X-axis with respect to the central flange 150, which is located in the center of the fixed body 102 and is the tallest compared to the other flanges 150. In this embodiment, the base 112 has a length (along the X-axis) of approximately 3.13 in. and a width that varies from approximately 1.5 in. at the center of the length of the base 112 to approximately 1.25 in. at the first and second ends 114, 116 (the flanges 150 follow this width range, with a thickness range ranging from 0.125 in. to approximately 0.25 in., and the length of the grooves 144 varying between approximately 0.125 in. and 0.75 in.), although these dimensions may be varied if desired for reasons including, but not limited to, varying the number of lines secured by the retainer 102 (by varying the number of gripping passages 142), varying the force applied to the secured lines, or varying the diameter of the lines being secured.Each groove 144 is preferably straight (as defined by two adjacent fixation flanges 150, by a segment flange 150 and a first end 114, or by a flange 150 and a second end 116), but may be curved or vary in shape if desired (see FIG. 13). It is important to note that the gripping passage 150 is preferably circular or cylindrical (to accommodate at least a portion of circular or cylindrical tubing), but may be other shapes to accommodate flexible tubing of other shapes. The diameter of the gripping passage 150 is specific to a particular range of IV line, tubing, or cord diameters to ensure proper optimum fixation. While medical tubing, lines, and cords do not conform to standard size guidelines, there is similarity between manufacturers over narrow enough size ranges that an average nominal line size can be determined that is common to a significant enough number of tubing, lines, and cords of a size to warrant a value used in sizing a common gripping passage 142 to accommodate each range of tubing, lines, and cords. Also, while there are an infinite number of wide-ranging lines, tubes, and cords, the nominal groupings chosen in this example are approximately 3 mm (or approximately 1 / 8") and approximately 6 mm (or approximately 1 / 4") in size. Each gripping passage 142 of the fixture 102 accommodates the width of the groove 144 required for manufacturability of the fixture 102 (preferably by injection molding or other molding process) and to allow insertion of a tube that matches the diameter of the particular gripping passage 150, such that when the fixture 102 is in a constrained state by tightening the retention straps 106, each groove 144 is closed or minimized by the respective flange 150, the flange 150 and the end 114 or 116 abut, the gripping passage 142 matches this nominal 3 mm (1 / 8") and 6 mm (1 / 4") diameter size, and the gripping passage 142 abuts the exterior surface around the circumference of the tubing being retained. A tight fit of the tubing into the gripping passage 142 is essential, as the size of the gripping passage 142 that most closely matches the tubing, line, or cord will be most effective in inhibiting line tension (and preventing tube withdrawal at the patient's insertion site).It is contemplated that the gripping passage 142 may have other nominal diameter sizes if desired for a particular application, and that the line fixture 102 may include any desired number of fixation flanges 150, and thus any desired number of gripping passages 142 and grooves 144. Similarly, the gripping passage 142 should be as close to circular in shape as possible to provide a strong grip all around the tubing being secured, and to provide a uniform load around the tubing being held to prevent fluid blockage within the tubing. If the gripping passage 142 were elliptical, square, triangular, or anything other than circular (assuming a circular tube is being held by the gripping passage 142), the gripping force exerted on the tubing held within the gripping passage 150 would not be consistent around the circumference of the tubing and would be weaker compared to a circular shape. The first end 114 is located at one end of the fixture 102 (along the X-axis) and may be generally curved or partially teardrop shaped on one side and may also include a flange 150, and the second end 116 is located at the opposite end of the fixture 102 (also along the X-axis) and is generally curved in the opposite direction from the first end 114 and may include an extension 168 that projects in the opposite direction from the flange 150, which helps to form the gripping passage 150 and groove 144 between the end 116 and the adjacent flange 150.

[0023] If compression of the retainer 102 by the retainer strap 106 creates a pulling force on the line secured in the gripping passage 142 (causing the IV line, tubing, or cord to drag or be pulled), the pulling force is absorbed in the device 100 by transferring the pulling force from the device 100 to a fixed structure (e.g., the patient's arm) so that the patient's insertion site is not affected. The retainer device 100 easily absorbs pulling forces of 20 lbs. or more (see below for further explanation), and preferably up to 80 lbs. or more. To provide some context regarding the importance of absorbing pulling forces of at least 20 lbs. or more, a central venous catheter can be withdrawn with a pulling force of just between 4-9 lbs. Furthermore, the design of the device 100 does not crush or crimp the line, allowing safe fluid flow even under tight gripping conditions.

[0024] The base 112 of the fixation body 102 further includes a strap aperture 148 formed therethrough and configured to allow the strap 118 to extend through the strap aperture 148. The strap aperture 148 is located above the top layer 120 of the armband 104 to allow movement of the strap 118 through the strap aperture 148 for various needs of a user (such as placing one or more transducers at a first end of the strap 118 or providing additional length to the armband 104 for fixation). In this embodiment, the strap aperture 148 is approximately 1 inch along the X-axis and approximately 1.5 in. along the Y-axis, although the size and configuration of the strap aperture 148 may be varied if desired. The strap opening 148 is rectangular with rounded corners and is approximately 0.0625 in. (1.59 mm) high along the Z axis, 1 in. (25.4 mm) along the X axis, and 1.56 in. (39.6 mm) along the Y axis, but may be configured in different shapes and sizes if desired.

[0025] 5 and 6, perspective and top views of an embodiment of the stationary body 102 are shown. The stationary body 102 further includes a first protrusion 130 coupled to the base 112 and extending away from the base 112 (along the Y-axis) perpendicular to each flange 150 and parallel to each gripping passage 142, and a second protrusion 132 coupled to the base 112 and extending away from the base 112 (along the Y-axis) perpendicular to each flange 150 and parallel to each gripping passage 142, the second protrusion 132 being a mirror image of the first protrusion 130 and located on the opposite wall from the first protrusion 130. Both the first protrusion 130 and the second protrusion 132 are generally rectangular with rounded corners, but may be configured in different shapes and arrangements if desired for optimal joining to the armband 104 alternatively. The first protrusion 130 and the second protrusion 132 are configured to be sandwiched between the upper layer 120 and the lower layer 122 and to secure, preferably permanently, the fixation body 102 to the arm band 104. The securing of the fixation body 102 to the arm band 104 is important and significant to ensure that the device 100 can withstand a pulling force of 20 lbs. or more on the tubing, line, or cable secured within the gripping channel 142 and transfer the pulling force to the fixation body 102 to which the device 100 is attached. Referring now to FIG. 6, as mentioned above, the widths of the flange 150, the first end 114, and the second end 150 may vary and in this embodiment form an overall curvilinear shape.The bottom of the base 112 is flat (although due to the material from which the fixture 102 is made, the base 112 is flexible) to allow for easy part measurement for improved quality assurance practices during molding / manufacturing and easy machining for assembly and bonding to the top and bottom layers 120, 122, but is sufficiently flexible so that when tensioned by the fixture 102, the fixture 102 deforms and the flanges 150 contact each other (and / or the first and second ends 114, 116). The overlap reduces the size of groove 144, causing gripping passage 142 to press against the portion of the fixed tubing secured within gripping passage 142, causing the shape of fixture 102 to be symmetrical or nearly symmetrical along the XZ plane, allowing for a more uniform hoop stress to be applied to the tubing secured within gripping passage 142 (a uniform compressive force / load is applied around the circumference of the tubing portion held within fixture 102, providing optimal strain relief from tubing pulling forces by device 100) (see FIG. 7B).

[0026] 2 and 4, the securing strap 106 is made of a flexible material and has a top surface 154, a bottom surface 156, and a buckle 138 secured to one end. The securing strap 106 further includes a hook fastener portion 128 located on the bottom surface 156, near the end of the strap 106 opposite the buckle 138, and extending toward the buckle 138 approximately 2.5 in. in this embodiment (although other sizes may be used), and a loop fastener portion 146, also on the bottom surface 156, extending approximately 6.5 in. from the buckle 138 to the loop fastener portion 146, although other configurations may be used if desired. It should be noted that the width of the securing straps 106 is important, and since in this embodiment the width is approximately 1 inch, it has been found that with the current size characteristics of the fixture 102, a securing strap 106 width narrower than 1 inch will exert more pressure on the lines secured within each gripping passage 142 compared to a securing strap 106 width of 1 inch at the same tension (approximately 10 lbs. in this embodiment), and may be useful in some embodiments. In use, the securing straps 106 are tightened around the fixture 102 in the XZ plane, thereby forcing the flanges 150 to contact or overlap and compressing the fixture 102 around the tubing contained within each gripping passage 142, thereby securing the tubing from moving within the fixture 102 due to pulling or dragging. The top surface 154 of the fastening strap 106 is in slidable contact with the fastening body 102 along the XZ plane, and the fastening strap 106 is threaded through the buckle 138 such that the loop fastener portion 146 is in contact with the hook fastener portion 128 at a desired tension, although it is contemplated that at least a portion of the fastening strap 106 may be secured to the fastening body 102 or arm band 104. The tension that the fastening strap 106 applies to the fastening body 102 is variable and dependent upon the length of the fastening strap 106 threaded through the buckle 138. Velcro® brand is preferred, although other types and brands of material may be used for the loop fastener portion 146 and the hook fastener portion 128.Additionally, the fastening straps 106 remain slidable between the bottom of the base 112 and the lower layer 122 of the armband 104, allowing for variable tension to be applied to the fastener 102. The fastening straps 106 are ideally made from Velcro®, although other fastening strap methodologies known in the art may be used, such as zip ties, strings, clamps, clasps, or elastomeric closure straps.

[0027] During pull testing of lines, tubes, and cords secured within the fixture 100, it was discovered that the orientation of the grooves 144 (and therefore the orientation of the flanges 150) that allow the insertion or removal of the lines creates a slight weakness in the fixture 102 when a pull is applied in line with the grooves 144, even when the fixture 102 is under compression by the fixation straps 106. Therefore, to reduce the likelihood that a pull on a line secured to the fixture 100 will be along the direction of the grooves 144, since the patient and their arms are statistically upright during sitting, standing, and therapy, and most line pull is downward (towards the floor) due to gravity, the grooves 144 and fixture flanges 150 are configured to face upwards towards the top of the arm (or towards the person's head) when the fixture 100 is secured to the patient. The grooves 144 are then oriented in the direction that is least likely to cause line pull, thereby maximizing line retention. Additionally, the angle of each securing flange 150 (and therefore the angle of each groove 144) allows each securing flange 150 to overlap an adjacent securing flange 150 or second end 116 (and allows first end 114 to overlap an adjacent flange 150) to provide a compressive load to an IV line, tubing, or cord within each gripping passage 142 when the securing strap 106 is tightened (e.g., a strap force of 10 lbs. may be adequate to provide at least 20 lbs. of strain relief on a line or tubing secured within the gripping passage 142). On the other hand, if each securing flange 150 (and therefore each groove 144) were simply oriented vertically (or perpendicular to the base 112), the line, tube, or cord could buckle.

[0028] 7A and 7B, a left side view of an embodiment of the fixation body 102 is shown without the first and second portions 130, 132, before and after compression by the fixation straps 106 (not shown). Numerous tests have shown that the preferred angle of the fixation flanges 150 to allow for ease of cord insertion, cord removal, and maximum cord securement due to the even overlapping nature of the flanges 150, to secure a line within each gripping passage 142, and to transfer compressive loads through the fixation body when under load is between 20 and 50 degrees (relative to the base 112) when the fixation straps 106 are unclamped, and approximately 35 degrees (relative to the base 112) when the fixation straps 106 are clamped and a compressive load is applied to an IV line, tubing, or cord within each gripping passage 150. It is contemplated that the angle of each fastening flange 150 may vary depending on what is desired to be fastened, the general direction in which the pulling force will occur, the material of the line fastener, and the diameter size of the gripping passage.

[0029] The retainer 100 is an elastomeric system that uses tension set by the retainer straps 106 around the retainer 102 to distort the retainer 102 and apply a compressive load created by the retainer straps 106 to the IV line in the gripping passage 150 at an analog, i.e., infinitely adjustable, tension level between open and closed positions to hold the IV line with high force without compressing the IV line by pinching it or in a manner that would obstruct fluid flow in the flexible line. Additionally, as mentioned above, the first end 114 and the second end 116 sandwich the retainer flange 150, and the first end 114, the second end 116, and the flange 150 are all aligned with one another and configured in a curvilinear shape. This type of shape allows the retainer 102 to securely grip IV lines, tubing, and cords while having decorative and aesthetically pleasing properties. This type of shape acts to more uniformly transfer and transmit loads (tension or pull on the IV lines, tubing, and cables) on the IV lines, tubing, and cables held within each gripping passage 142 by providing more surface area to grip the held lines, tubing, and cables. When the fixation straps 106 are tightened to compress the fixation body 102 to encircle and grip the IV line, tubing, or cable (within the gripping passage 150), the fixation body 102 displaces to a balanced shape and exerts equal forces around each gripping passage on the lines secured within each gripping passage 150. The fixation straps 106 close the grooves 144 between the flanges 150, first end 114, and second end 116 that were used to initially install the lines within the gripping passage 142, forcing the line fixation body 102 to a more uniform elliptical shape (see FIG. 7B). This elliptical shape then transfers the force of the fixation strap 106 to the IV line, tubing, or cable through a physical phenomenon known as hoop stress.A cylindrical or circular shaped fastener 102 would theoretically be ideally balanced and would provide the most strength to all lines in such an embodiment (due to the width of the groove 144 allowing the lines to be inserted), but would likely be less comfortable for the patient and would result in a large and difficult to attach device due to its size or height from the armband 104. A circular shaped fastener 102 may be desired for maximum ability to resist pulling forces when a maximum amount of fastening is desired and the device 100 does not necessarily need to conform to the patient's arm. Thus, a curved or trimmed semicircular shaped fastener 102 in combination with an armband 104 provides the best balance of manufacturability, weight, size, performance, and patient comfort for fastening lines, tubing, and cords. It is also contemplated that the curvature of the curve, at least in the XZ plane, mentioned above, may be altered if desired. The greater the amount of curvature of the flanges 150, first end 114, and second end 116 of the fixation body 102 when in a secured and compressed state (when the fixation straps 106 are tightened and the fixation flanges 150 overlap one another), the greater the amount of resistance that can be transferred to the IV line, tubing, or cord secured by the gripping passage 150 in the event of a line pull.

[0030] The retainer 102 is a tacky elastomeric material, where the key is a balance between ease of tube insertion, safety and comfort for the patient, and the strength of the device 100 to maintain compression of the inserted tube to prevent migration of the tube inserted within the retainer 102 under a pulling force of at least 9 lbs., but preferably up to 20 lbs. The material properties of the retainer 102 may be changed as desired for different situations. For example, for life-saving aviation or military applications, and where additional retention is desired, the shape may be altered for a stronger overall grip on the inserted tubing, or the hardness of the retainer 102 material may be changed to increase grip strength around the line being held, at the expense of ease of installation. In a preferred embodiment, the device 100 can withstand a pulling force of at least 20 lbs. in any direction (along the X, Y, or Z axes), but preferably up to 80 lbs. or more between all lines held by the device (assuming that approximately 10 lbs. of force is used to secure the securing straps 106 around the fixture 102). That is, the device will withstand 20 lbs. of force applied to one line secured within the gripping channel 142, or 5 lbs. of force applied to each of four lines secured within the four gripping channels 142. The device's ability to withstand a pulling force of 20 lbs. or more is a significant improvement over current solutions and solves a long-standing problem. However, it is important to note that the amount of pulling force that the device 100 can relieve depends on many factors, including but not limited to, the tension of the fixation straps 106 applied to the fixation body 102, the diameter of the cords, lines, and tubes secured within the gripping channel 142, and whether the lines, tubes, and cords are rigid / stiff or flexible / soft. Additionally, the directional vector of the pulling force applied to the lines, tubes, and cords and the speed at which the pulling force is applied can also be a factor.

[0031] 8 and 9, there are shown a front perspective view of an alternative embodiment of the present invention in which a transducer 158 is attached to the top layer 120 of an arm band 104 by a first end 108 of a strap 118, and a perspective view of the alternative embodiment of the present invention attached to a 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 and 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 top layer 120 by fastening the hook fastener of the first end 108 to the loop fastener of the top surface 134 of the top layer 120 of the arm band 104. The first end 108 of the strap 118 is configured here to secure up to three transducers 158 aligned with one another to the arm band 104, although the first end 108 may be made longer or shorter to accommodate a different number of transducers 158 or other devices that may be desired to be secured to the securing device 100. Referring now to Figure 11, the location and position of the first end 108 of the strap 118 is important in transducer use, as each transducer 158, device 100, through placement of the arm band 104 on the patient, allows for accurate positioning of the transducer 158 to be aligned or flush with the right atrium of the patient's heart 230 (see dotted lines), which is essential for accurate monitoring of life support medication based on real-time blood pressure readings by the transducer 158. Transducers are designed to be placed on an IV pole, but more commonly are attached to the patient's gown by a clothespin, taped to the arm, or using products intended to hold the catheter in place in the patient's leg, but unfortunately always fall off the patient's arm, causing unnecessary and potentially life-threatening disruptions.None of these methods allow for proper fixation of the transducer in the correct position as mentioned above by device 100, which is critical for proper hemodynamic monitoring after a procedure such as open heart surgery or transplantation.

[0032] 10 and 11, perspective views of an alternative embodiment of the present invention are shown connected to a patient and secured to a stationary object. In essence, the medical line strain relief securement device 100 is a strain relief device and system in which the device provides the unique ability to transfer tension in an IV line from a force vector, such as a pull or drag, to the device 100 on the patient's arm rather than to the IV line insertion site into the patient, preventing painful line pulling and dangerous dislodgment at the patient's insertion site. An example of this is illustrated in FIG. 10, where the device 100 separates at least one line 222 (four lines in this example) attached to a patient into a load side 224 and a fixed side 226. When the line on the load side 224 of the device 100 is subjected to a force vector, such as a drag, the device 100 absorbs the force vector and transfers it to the patient's arm rather than conducting it to the fixed side 226 of the line which is connected to the patient's insertion site (where the line is attached to the patient's skin or body, or where it extends into the patient's skin or body), thereby potentially preventing pain and trauma from the force vector to the patient. When the secured line 222 is not under load, the securement device 100 still exerts a constant compressive gripping force on the line 222, but the patient does not feel it. That is, a compressive load from the securement strap 106 is constantly applied by the securement body 102 to hold the IV line 222 in place, and that compressive load is independent of the arm band 104 which encircles the patient's arm, ensuring that the device 100 is always ready to protect against drag or pulling. That is, the compressive load on the fixation body 102 is independent (and can be independently adjusted) from the force used to tighten the arm band 104 around the patient's arm. The compressive load on the fixation body 102 by the fixation straps 106 causes the fixation body 102 to assume an elliptical shape, promoting an even distribution of the compressive load on the fixed lines 222 around the circumference of each line 222, ensuring a strong grip on each line 222.However, when an external tension or pulling force is applied to the line 222 secured within the fixture 102, the load is transferred to the fixture 102 which exerts a compressive load on the line, to the arm band 104 and then conducted to the patient's arm (or other fixed structure). Referring now to Figure 11, the device 100 is secured around a pole, such as an IV pole, by the arm band 104.

[0033] 12A and 12B, perspective views of another alternative embodiment of the present invention are shown in an open and closed (or compressed) position. In this alternative embodiment, the armband 104 may include one or more separate fasteners 200 secured to the armband 104 in the same manner as the fastener 102 (by sandwiching first and second protrusions (not shown) located on a base 212 of the fastener 200 between the upper layer 120 and the lower layer 122 of the armband 104). The fastener 200 includes a base 212 having a fastener strap 202 (replacing the fastener strap 106 of the previous embodiment) integrally formed therewith, and a single fastener flange 204 and a single end 206 forming a gripping passage 214 and a groove 216, the fastener strap 202, the fastener flange 204, and the end 206 are all coupled to the base 212. The end 206 further includes a protrusion 208 extending away from the fastening flange 204. The fastening strap 202 further includes at least one aperture 210 formed therethrough and configured to be fastened over the protrusion 208, which substantially corresponds to a hook feature for retaining the aperture 210. By fastening different apertures 210, the tension applied to the fastening body 200 can be varied, with apertures 210 formed closer to where the fastening strap 202 is coupled to the base 212 creating more tension on the fastening body 200 and apertures 210 formed in the fastening strap 202 formed further from the base 212 creating less tension on the fastening body 202. Such an embodiment allows a single line to be removed or adjusted at a particular fastening body 200 when multiple fastening bodies 200 are disposed on a single armband 104, without affecting the tension of any adjacent fastening bodies 200 or the lines to which they are fastened. In the open position, the line may be placed into the gripping passage 214 via the groove 216 .In the closed position, the line is secured within the gripping passage 214 with the securing strap 202 overlapping the securing flange and terminus 206, thereby placing the opening 210 of the strap 202 over the protrusion 208 of the terminus 206, thereby providing tension to the securement body 200 and the line held within the gripping passage 214. Additionally, in any embodiment, it is contemplated that the width of each groove 216 of the securement body 202 may be increased or adjusted along with modifications to the shape or material selection of the securement body 202 to allow for easier insertion of an IV line, tubing, or cord to be placed within the gripping passage 214.

[0034] 13, a left side view of an alternative embodiment of the retainer 102 is shown (without the first protrusion 130 or second protrusion 132 and with the retainer strap 106 under tension). In this embodiment, the retainer flange 150 and groove 144 may be configured to curve in a "serpentine path" type groove. Such a configuration may prevent the line 222 held within the gripping passage 142 from being pulled in a straight line direction out of the gripping passage 142 and groove 144, which would be the path of least resistance for a force vector 218 or 220 in that direction. The curved flange 150 and groove 144 configuration significantly reduces the likelihood of a straight line pull (whether the groove is vertical or angled) since the force vector is typically linear and pulled from a fixed location and position. The curved or zigzag shape of the groove 144 provides a secondary defense against pulling on the straight line 222 straight out of the retainer 102 by a "pinching" effect and friction applied to the line to keep it in the correct position when it is under tension. If the line is pulled through the groove 144 and under load against the retainer strap 106, it would otherwise have little load reduction capacity in the event of a large line pull force. After such a line pull occurs, inspection of the armband should be performed to ensure the line is back in the correct gripping path.

[0035] A method of using the retainer 100 involves first configuring the retainer 100, having at least one groove 144, at least one flange 150, a first end 114, a second end 116, and a retainer strap 106 around the retainer, so that each groove 144 of the retainer 102 faces up or toward the sky. The medical tubing, IV line, and / or cord is then inserted into the gripping passage 142 of the retainer 102 that most closely matches the size of the line diameter (with the retainer 100 in an open position). The retainer strap 106 is then fastened and tightened to bring each flange 150 into contact with an adjacent flange 150 or the second end 116 (with the retainer 100 in a closed position). Additionally, if a destructive or harmful load is applied to device 100, the flow of fluid through the line and drug delivery to the patient will not be altered or impaired because the line will not be completely pinched if it is in this position shown by line 222 or in any of the mentioned embodiments, due to the design, shape, size, and materials of device 100 as described herein.

[0036] Although the present invention has been described above with reference to specific embodiments, it should be understood that the present invention is not limited to these disclosed embodiments. Many modifications and other embodiments of the present invention will occur to those skilled in the art to which the present invention pertains, and are intended to be encompassed by both this disclosure and the appended claims. Rather, it is intended that the scope of the present invention should be determined by the proper interpretation and interpretation of the appended claims and their legal equivalents, as understood by those skilled in the art in reliance on the present disclosure in accordance with this specification and the accompanying drawings. Similarly, when this document refers to technology that would be obvious or known to a person skilled in the art, such technology encompasses technology that is obvious or known to a person skilled in the art at any time now or in the future.

Claims

1. A fixing band and a fastener attached to the fastening band and configured to fasten at least a portion of at least one tube, line, or cord; a fastening strap configured to apply a variable tension to the fastener; a strap attached to the retention band and configured to secure the retention band around a retention structure; and Equipped with the retainer is configured to, when under tension, apply a compressive load to the portion of the at least one line, tube, or cord to secure the portion of the at least one line, tube, or cord against movement; Fixtures.

2. 10. The fastener of claim 1, wherein the fastener is configured to provide a uniform compressive load about a circumference of the fastened portion of the at least one line, tube, or cord when under tension.

3. 10. The fixation device of claim 1, wherein the fixation body is configured to absorb and transmit forces applied to the fixed line, tube, or cord to the fixation band when under tension.

4. 3. The fastener of claim 2, wherein the fastener is configured to prevent movement of the fastened portion of the at least one line, tube, or cord due to a pulling force of at least 9 lbs. applied to the at least one line, tube, or cord.

5. The fixation device of claim 1 , wherein the strap is configured to extend through the fixation body.

6. 2. The fixation device of claim 1, wherein the armband further comprises an upper layer having an opening formed therethrough and a lower layer, and a portion of the fixation body is fixed between the upper layer and the lower layer.

7. The fixation device of claim 6 , wherein the fixation body extends partially through the opening in the upper layer.

8. 7. The fixation device of claim 6, wherein the bottom layer is made of USP Class VI medical grade material.

9. The fixation device of claim 1 , wherein the fixation strap is configured to encircle the fixation body along a plane.

10. A fixing band and a fixture attached to the fixture band, the fixture including an opening formed therethrough and configured to hold at least one tube, line, or cord; A fastening strap configured to apply tension to the fastener; a strap attached to the retention band and configured to secure the retention band around a retention structure; and Equipped with the fixture is configured, when under tension, to prevent movement within the fixture of at least a portion of the line held by the fixture due to a pulling force. Fixtures.

11. The fixed body is A base and a strap aperture formed in the base and configured to cooperate with the strap; at least one gripping passageway formed within the base and configured to hold a line; at least one flange coupled to the base and to the at least one gripping passage; At least one end Including, the at least one flange and the second flange or the at least one end define a groove connected to the gripping passage; The fixation device of claim 10.

12. The fixation device of claim 10 , wherein the at least one flange is at an angle of between 20 degrees and 50 degrees relative to the base.

13. The fixed body is a first projection extending from the base; a second projection extending from the base; and Further comprising: The first protrusion and the second protrusion are configured to attach the fixation body to the fixation band. The fixation device of claim 10.

14. The fixation device of claim 10 , wherein one end of the strap is configured to secure at least one transducer to the fixation band and extend through the opening in the base.

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

16. The fixation device according to claim 10 , wherein the fixation body is made of an adhesive elastomer.

17. securing a fastening band to a stationary structure, the fastener including a fastener having a fastening strap, at least one gripping passage, and at least one flange, the at least one flange extending upward; inserting a tube, line, or cord into the at least one gripping passage; tightening the fastener strap around the fastener to compress the fastener against at least a portion of the tube, line, or cord to prevent movement of at least the portion of the tube, line, or cord; A method for fastening a line to a fixture, comprising:

18. 20. The method of claim 17, wherein the diameter of the gripping passage approximately matches an outer diameter of the tube, line, or cord.

19. 20. The method of claim 17, wherein the portion of the fixture forming the at least one gripping passage is compressed around a circumference of the tube, line, or cord.

20. The method of claim 17 , wherein the retainer further comprises a strap.

21. 20. The method of claim 17, wherein the retainer protects the portion of tubing, line, or cord within the retainer from a pulling force of at least 9 lbs.

22. a fastening band configured to be removably attached to a fixed structure by tension; and a fixing body attached to the fixing band and configured to fix at least one line; A fastening strap configured to apply tension to the fastener; Equipped with the fixator is configured, when under tension by the fixation strap, to separate the at least one line fixed by the fixator into a load side and a fixed side, and the fixator is configured to conduct a load applied to the load side of the at least one line to the fixator and thereafter to a fixed structure rather than to the fixed side of the line; Fixtures.

23. 23. The fixation device of claim 22, wherein the tension of the fixation band can be different from and independently adjustable from the tension of the fixation strap on the fixation body.

24. 23. The fixation device of claim 22, wherein the fixation straps are made integral with the fixation body.

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