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 lack 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 patients need to be mobilized. Currently, 19 million line pulls occur annually in the United States, and the problem is underreported. Mobilization includes patient transport or transfers, bed transfers, physician movement around the patient or bed, patient tasks such as sitting up, standing, transferring to a chair, walking to the toilet, or performing rehabilitation therapy. Currently, 64% of early mobilization therapies in intensive care unit (ICU) settings are used to untie and secure lines.

[0004] Following an invasive procedure or trauma, early mobilization therapy is one of the best approaches to speeding recovery. However, many critically ill hospitalized patients have multiple lines and cords connected to life-saving medical devices. During early mobilization therapy, these connections create real problems and barriers, as patients experience discomfort, pain, and the fear of serious trauma. It is human nature to avoid repeating an activity if discomfort is felt. Therefore, if discomfort is felt during therapy from lines pulling on the line insertion site, the patient may not want to undergo that therapy again, potentially hindering the patient's ability to heal. Even worse, lines may be accidentally pulled from the patient's insertion site, and the lines may contain life-support lines or diagnostic monitoring equipment necessary for life support. If a life-support line is pulled from the insertion site, patient death may occur unless emergency intervention is performed quickly and appropriately. Several types of trauma, from psychological fear to physical pain and the risk of death, can hinder the desire to undergo necessary therapy to promote recovery.

[0005] Tape or adhesive and sutured lines are commonly used methods for securing lines to a patient's skin at the insertion site. This has many drawbacks, including bothersome discomfort, skin tears, skin irritation, plaque, and skin infection. Adhesives provide only a minimal amount of strength to grip the line, 17.64~40.18N( 1.8~4.1kg f (4-9 lbs f .) )The pulling force between the IV lines and cords can pull apart typical adhesives. Physicians have also used tape and medication cups or tongue depressors to gather IV lines and cords on bed rails, or have used rolled incontinence pads, taped the IV lines to the pads, and then fastened them to the patient's clothing, but these attempts have provided minimal security and have not been very successful. Line pulling and pull-out is a known problem, and the solutions mentioned are the best that resourceful physicians have come up with in an attempt to provide some controlled means of providing some safety to the patient. Currently, reliable, reusable, and reliable IV line and cord clamps are available to secure multiple IV lines, tubing, and cords in one place while also providing at least one additional layer of protection against punctures and punctures applied to the lines, tubing, or cords. 40.18N( 4.1kg f (9lb f .) ) There is nothing available to provide strain relief for pulling forces up to and beyond. 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 point 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 point, such as may routinely occur during patient transfer, treatment, or therapy in a hospital or medical environment.

[0007] Another object of the present invention is to provide a device 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 including an armband, a fixation body attached to the armband, a fixation strap configured to displace the fixation body, and the strap attached to the armband, which is utilized to secure the armband to a fixed structure such as a patient, a bed, an IV pole, crutches, etc. The fixation body is configured to securely hold at least one line, tube, or cord, and the strap can further secure at least one transducer or another device 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 fixed body comprises: 40.18N( 4.1kg f (9lb f .) ) , or 89.18N( 9.1kg f (20lb f .) ) , or even 311.64N( 31.8kg f (70lb f .) ) It may be of a shape and material composition designed to provide a particular amount of such tension relief.

[0011] The present invention also relates to a method for mitigating undesired removal of lines, tubes, and cords attached to a patient, comprising first securing a securement device having a securement strap, at least one gripping passage, and at least one flange, the flange extending toward the top of the securement body around an immobilization structure, such as the patient's arm, with the flange and groove of the securement device facing upward. Next, the lines, tubes, and cords attached to the patient at an insertion site on the patient are each attached to the securement device. Finally, the securement body is compressed, bringing each flange into contact with an adjacent flange and reducing the width of each groove, thereby securing the securement device to the lines, tubes, and cords. Even if any of the secured lines, tubes, or cords are pulled or tugged, the pulling force caused by the pulling or tugging is mitigated by the device, so that the lines, tubes, and cords inserted into the patient remain in the correct position at the insertion site without being affected. [Brief explanation of the drawings]

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

[0013] For the terms defined below, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​herein are deemed to be modified by the term "about," whether expressly stated or not. 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-numeric contexts) may be deemed to have the ordinary and accustomed definition as understood from and consistent with the context of this specification, unless expressly stated otherwise.

[0014] For the terms defined below, these definitions shall apply 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 in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context 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 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 plural 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 interchangeable and are intended to mean any flexible, medical-grade material used to carry fluids, gases, information, or electricity.

[0017] 1-13, a medical line strain relief securement device, system, and method will be described. Referring to the accompanying drawings, wherein reference numerals indicate corresponding elements throughout the several views, and initially to FIG. 1, a rear perspective view illustrating the composition of an embodiment of the present invention is shown, with reference numeral 100 indicating the entire device. The medical line strain relief securement device 100 is designed to eliminate dangerous pulling and line or cord disconnection 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 medical tubing, lines, and cords of various sizes and types along the X, Y, and Z axes against pulling forces along the X, Y, and Z axes. Securement device 100 is also designed to be easily manufacturable, include a minimal set of components, 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 securement device 100 are the result of over 30 design iterations and thousands of hours of labor. Securement device 100 includes a line securement 102 made of an adhesive elastomeric material affixed to a flexible securement band 104, such as an armband (note that while this term is used to refer to element 104, armband 104 is not limited to securement around a patient's arm). In a preferred embodiment, line securement 102 is permanently attached to armband 104 (such as by molding, adhesive, Velcro®, suturing, ultrasonic welding, or other methods), but may also 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, the retainer strap 106 being configured to apply 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 securement device 100 further includes a strap 118 extending through the securement body 102 and including a first end 108 configured to be removably coupled to the armband 104 to fasten and secure the armband 104 around a user's arm or other secure 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 comfortably wraps around a fixed structure, such as a patient's appendage, such as an arm or leg, without adhesive, just like a blood pressure cuff. Note that by clever shape modifications to the fixation body 102 via the armband 104, the fixation device 100 may be configured to be attached to a patient by other means than the arm or leg, such as in situations involving ECMO tubing, femoral catheters, Swan Ganz, oncology, labor and delivery, respiratory tubing, life support aviation, neonatal ICU (NICU), military, or other situations where line strain relief is desired. The armband 104 can also be attached to any conceivable rigid object, such as, but not limited to, an IV pole or bed rail, and is intended to move with the patient. A 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 the appropriate 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 and a perspective view of an embodiment of the present invention are shown, in which the armband 104 includes at least an upper layer 120 having a body opening 124 formed therethrough and configured to allow a portion of the retainer 102 to extend therethrough, and a lower layer 122 underlying the upper layer 120 and the retainer 102, with adhesive positioned between the upper layer 120 and the lower layer 122 (a portion of the retainer 102 also positioned between the upper layer 120 and the lower layer 122) such that a portion of the retainer 102 (a base 112, a first portion 130, and a second portion 132, described below) remains beneath the upper layer 120, adhering the layers (preferably permanently) to the retainer 102, thereby securely sandwiching the retainer 102 to the armband 104 (by the first portion 130 and the second portion 132, described below). The body opening 124 is shaped around the periphery of the stationary body 102 along the X-axis and Y-axis (in the X-Y plane), excluding the first protrusion 130 or the second protrusion 132 (described below) of the base 112 (the periphery of the flange 150, first end 114, and second end 116, described below), and is rectangular with rounded corners and curved long sides. The body opening 124 is oriented (X-axis) with its long side extending across the width of the armband 104, although the opening 124 may be positioned in other locations and positions on the armband 104 as desired for cooperation with the stationary body 102. The top layer 120 is made of foam (or other flexible material, such as fabric, plastic, etc.) having an upper 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 the 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 example, artwork 140 includes the text "UP" accompanied by an arrow graphic and is located near one edge of the top surface of upper layer 120 to indicate that artwork 140 is located near the top of the patient's head or fixture and that device 100 should be oriented to aim in that direction. The orientation coincides with the orientation of fixture flange 150 and corresponding groove 144 (discussed below). Armband 104 further includes at least one notch 164, but preferably multiple notches 164 located across the width and at various locations along the length of upper and lower layers 120, 122, configured to allow armband 104 to be flexible for easy wrapping and securing around a fixture structure.

[0020] The lower layer 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 in a patient with prolonged wear of the device 100, and also provides a non-absorbent barrier to sweat and moisture. To apply the armband 104 to a patient, the armband 104 is placed around the patient's arm in direct skin contact rather than through clothing. The lower layer 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 provided by a flexible neoprene knee brace to stay in place), without requiring 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 inches long along the Y axis and 4 inches wide along the X axis, with notches 164 spaced approximately every 1 inch along the length of the armband 104 and the center of the main opening 124 located approximately 2 inches from one longitudinal end of the armband 104.

[0021] The strap 118 preferably includes Velcro® hook fastener material on at least one side, with the first end 108 being wider along the X-axis (approximately 1.88 in.) and longer along the Y-axis (approximately 3 in.) than the second end 110 (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 armband 104, ensuring releasable attachment of the strap 118 to the armband 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 fixture 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, integrally formed with and extending away from the base 112 and positioned (or sandwiched) between the first end 114 and the second end 116, with each flange 150 aligned with one another and with the first end 114 and the second end 116. The fixture 102 further includes at least one gripping passage 142, formed along the Y-axis through the base 112, having a generally circular or cylindrical 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. Grip passages 142 are located between first end 114 and at least one flange 150, between at least one flange 150 and another flange 150, and between flange 150 and second end 116. Each gripping passage 142 is further connected to a groove 144 extending away from the gripping passage 142, which is configured to allow the tubing, 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 the first end 114, or by a flange 150 and the 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 force to the retained line or tube around the circumference of the retained line or tube, thereby properly securing the tubing within the gripping channel 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 subsequent flanges 150 decreasing in length (along the Y axis) toward the first end 114 and second end 116, creating a tapered 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 two or more flanges 150 are 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 is approximately 3.13 inches (79.4 mm) long (along the X-axis) and has a width that is approximately 1.5 inches (38.1 mm) at the center of the length of the base 112 and gradually decreases therefrom to approximately 1.25 inches (31.8 mm) wide at the first end 114 and the second end 116 (the flange 150 follows this width range, with a thickness range of 0.125 inches (3.18 mm) to approximately 0.25 inches (6.35 mm), and the length of the groove 144 varies between approximately 0.125 inches (3.18 mm) and 0.75 inches (19.05 mm)). However, these dimensions may be varied as desired for reasons including, but not limited to, varying the number of lines secured by the retainer 102 (by varying the number of gripping channels 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 the first end 114, or by a flange 150 and the 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, optimal 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 range of tubing, lines, and cords to warrant a value used in sizing a common gripping passage 142 to accommodate each range of tubing, lines, and cords. Also, while an infinite variety of lines, tubing, and cords exist, 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 required groove 144 width for manufacturability of the fixture 102 (preferably by injection molding or other molding process) and to allow insertion of tubing that matches the particular gripping passage 150 diameter, such that when the fixture 102 is constrained 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 abutting, the gripping passage 142 conforming to this nominal 3 mm (1 / 8") and 6 mm (1 / 4") diameter size, and the gripping passage 142 abuts the outer surface around the circumference of the retained tubing. 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 passages 142 may have other nominal diameter sizes if desired for a particular application, and that the line fixation body 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 passages 142 should be as nearly circular as possible so as to provide a strong grip all around the tubing being fixed and to provide a uniform load around the tubing being held to prevent fluid blockage within the tubing. If the gripping passages 142 were oval, square, triangular, or anything other than circular (assuming a circular tube is being held by the gripping passages 142), the gripping force exerted on the tubing held within the gripping passages 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, while 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 securement body 102 by the securement strap 106 causes a pulling force on the line secured in the gripping channel 142 (such as dragging or pulling on the IV line, tubing, or cord), the pulling force is relieved in the device 100 by transferring the pulling force from the device 100 to the anchoring structure (e.g., the patient's arm) so that it does not affect the patient's insertion site. 89.18N( 9.1kg f (20lb f .) ) These tension forces are easily relieved (see below for further explanation), and preferably 355.74N( 36.3kg f (80lb f .) ) Easily relieves pulling forces up to at least89.18N( 9.1kg f (20lb f .) ) To provide some background on the importance of relieving these pulling forces, 17.64~40.18N( 1.8~4.1kg f (4-9 lbs f .) ) Furthermore, the design of the device 100 does not crush or crimp the line, allowing for safe fluid flow even under tight grip conditions.

[0024] The base 112 of the fixation body 102 further includes a strap opening 148 formed therethrough and configured to allow the strap 118 to extend therethrough. The strap opening 148 is located above the upper layer 120 of the armband 104 to allow movement of the strap 118 through the strap opening 148 for various user needs (such as placing one or more transducers at a first end of the strap 118 or providing additional length to the armband 104 for fastening). In this embodiment, the strap opening 148 is approximately 1 inch along the X-axis and 1.5 inches along the Y-axis, although the size and configuration of the strap opening 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 perpendicular to each flange 150, parallel to each gripping channel 142, and away from the base 112 (along the Y-axis), and a second protrusion 132 coupled to the base 112 and extending perpendicular to each flange 150, parallel to each gripping channel 142, and away from the base 112 (along the Y-axis), 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 alternatives for optimal attachment to the armband 104. The first protrusion 130 and the second protrusion 132 are sandwiched between the upper layer 120 and the lower layer 122 and are configured to secure, preferably permanently, the retainer 102 to the armband 104. The securing of the retainer 102 to the armband 104 occurs when the device 100 is resting on tubing, lines, or cables secured within the gripping channel 142. 89.18N( 9.1kg f (20lb f .) )6, as mentioned above, the widths of flange 150, first end 114, and second end 150 may vary, and in this embodiment, they form an overall curved shape. The bottom of base 112 is flat (although base 112 is flexible due to the material from which fixture 102 is made) to allow for easy part measurement for improved quality assurance practices during molding / manufacturing, and for easy engineering for assembly and bonding to top layer 120 and bottom layer 122, but is sufficiently flexible so that fixture 102 deforms and allows flanges 150 to move relative to each other (and / or relative to first end 114 and second end 116) when tensioned by fixation straps 106. The overlap reduces the size of the grooves 144, causing the gripping passage 142 to press against the portion of the tubing secured within the gripping passage 142, causing the shape of the 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 the gripping passage 142 (a uniform compressive force / load is applied around the circumference of the tubing portion held within the fixture 102, providing optimal strain relief from tubing pulling forces by the 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 inches in this example (although other sizes may be used), and a loop fastener portion 146, also on the bottom surface 156, extending approximately 6.5 inches 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 strap 106 is important, and since the width in this embodiment is approximately 1 inch, with the current size characteristics of the securing body 102, if the width of the securing strap 106 is narrower than 1 inch, the same tension (approximately 1 inch in this embodiment) will be applied. 44.1N( 4.5kg f (10lb f .)) )It has been found that the increased pressure exerted on the lines secured within each gripping channel 142 compared to the width of the securement straps 106, which is 25.4 mm (1 inch), can be useful in some embodiments. In use, the securement straps 106 are tightened around the securement body 102 in the XZ plane, thereby causing the flanges 150 to contact or overlap and compressing the securement body 102 around the tubing contained within each gripping channel 142, thereby securing the tubing against movement within the securement body 102 due to pulling or dragging. The upper surface 154 of the securement straps 106 is in slidable contact with the securement body 102 along the XZ plane, and the securement straps 106 are threaded through the buckle 138 so that the loop fastener portion 146 contacts the hook fastener portion 128 at a desired tension, although it is contemplated that at least a portion of the securement straps 106 may be secured to the securement body 102 or the armband 104. The tension that the securing strap 106 applies to the securement body 102 is variable and depends on the length of the securing strap 106 threaded through the buckle 138. While other types and brands of material may be used for the loop fastener portion 146 and the hook fastener portion 128, Velcro® brand is preferred. Additionally, the securing strap 106 remains 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 securement body 102. The securing strap 106 is ideally made of Velcro®, although other securing strap methodologies known in the art may be used, such as zip ties, string, clamps, clasps, or elastomeric closure straps.

[0027] During pull-force testing of lines, tubes, and cords secured within the securement device 100, it was discovered that the orientation of each groove 144 (and therefore the orientation of each flange 150), which allows for the insertion or removal of each line, creates a slight weakness in the securement device 102 when a pulling force is applied in line with the groove 144, even when the securement device 102 is under compression by the securement straps 106. Therefore, to reduce the likelihood that a pulling force on a line secured to the device 100 will be along the direction of the groove 144, since patients and their arms are statistically upright during sitting, standing, and therapy, and most line pull is downward (toward the floor) due to gravity, each groove 144 and securement flange 150 is configured to face upward, toward the top of the arm (or person's head) when the device 100 is secured to the patient. Thus, each groove 144 is oriented in the direction 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 with an adjacent securing flange 150 or second end 116 (and allows the first end 114 to overlap with an adjacent flange 150), allowing for compressive loading of an IV line, tubing, or cord within each gripping passage 142 when the securement strap 106 is tightened (e.g., at least one of the first and second ends 114 and 116 is applied to a line or tubing secured within the gripping passage 142). 89.18N( 9.1kg f (20lb f .) ) To provide tension relief, 44.1N( 4.5kg f (10lb f .) ) may be appropriate. 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, left side views of an embodiment of the fixation body 102 are 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 to allow for ease of cord insertion, cord removal, and maximum cord securement due to the even overlapping nature of the flanges 150, the preferred angle of the fixation flanges 150 to secure a line within each gripping channel 142 and transfer a compressive load 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 tightened and a compressive load is applied to an IV line, tubing, or cord within each gripping channel 150. It is contemplated that the angle of each securing flange 150 may vary depending on what is desired to be secured, the general direction in which the pulling force will occur, the material of the line securement, 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 within the gripping channel 150 at an analog, i.e., infinitely adjustable, tension level between open and closed states, thereby holding the IV line with high force without pinching the IV line or compressing it in a manner that obstructs fluid flow within the flexible line. Additionally, as mentioned above, the first end 114 and second end 116 sandwich the retainer flange 150, and the first end 114, second end 116, and flange 150 are all aligned with one another and configured in a curved 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 pulling on the IV line, tubing, and cable) on the IV line, tubing, and cable held within each gripping passage 142 by providing more surface area for gripping the held line, tubing, and cable. When the retaining straps 106 are tightened to compress the retainer 102 to surround and grip the IV line, tubing, or cable (within the gripping passage 150), the retainer 102 undergoes a large displacement into a balanced shape, exerting equal forces around each gripping passage on each line secured within each gripping passage 150. The retaining straps 106 close the grooves 144 between the flanges 150, first end 114, and second end 116 that were used to initially install the line within the gripping passage 142, forcing the line retainer 102 into a more uniform oval 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.While a cylindrical or circular shaped fixator 102 would theoretically be ideally balanced and would provide the greatest strength to all lines in such an embodiment (due to the width of the slots 144 through which the lines are inserted), it would likely be uncomfortable for the patient and would result in a device that is large and difficult to attach due to its size or height from the armband 104. In cases where the greatest amount of fixation is desired and the device 100 does not necessarily need to conform to the patient's arm, a circular shaped fixator 102 may be desirable for its greatest ability to resist pulling forces. Therefore, a curved or tailored semicircular shaped fixator 102 and armband 104 combination provides the best balance of manufacturability, weight, size, performance, and patient comfort for securement of lines, tubing, and cords. It is also contemplated that the curvature of the curve, at least in the XZ plane, mentioned above, may be varied if desired. The greater the amount of curvature of the flange 150, first end 114, and second end 116 of the fixation body 102 when in a secured and compressed state (when the fixation strap 106 is 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 fixation body 102 is an adhesive elastomer material, and the key factors are ease of tube insertion, safety and comfort for the patient, and at least 40.18N( 4.1kg f (9lb f .) ) Depending on the pulling force, preferably 89.18N( 9.1kg f (20lb f .) )The strength of the device 100 is a balance between maintaining compression of the inserted tubing within the fixator 102 to prevent movement of the inserted tubing due to pulling forces up to 100. The material properties of the fixator 102 may be changed as desired for different situations. For example, for life-saving aviation or military applications, and where additional fixation is desired, the shape may be changed for a stronger overall grip on the inserted tubing, or the hardness of the material of the fixator 102 may be changed to increase the grip strength around the line being held, at the expense of ease of installation. In a preferred embodiment, the device 100 provides at least 100 mm of force in any direction (along the X, Y, or Z axes). 89.18N( 9.1kg f (20lb f .) ) between all lines held by the device. 355.74N( 36.3kg f (80lb f .) ) (The securing strap 106 can be secured around the securing body 102 with a force of approximately 44.1N( 4.5kg f (10lb f .) ) (Assume a force of 100 psi is used.) That is, the tool is attached to a line fixed within the gripping channel 142. 89.18N( 9.1kg f (20lb f .) ) or the force applied to each of the four lines fixed within the four gripping channels 142. 22.54N( 2.3kg f (5lb f .) ) The force of the device is reduced. 89.18N( 9.1kg f (20lb f .) )The ability to withstand these pulling forces 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 is able to absorb 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 tubing secured within the gripping channel 142, and whether the lines, tubing, and cords are rigid / stiff or flexible / soft. Additionally, the directional vector of the pulling force applied to the lines, tubing, and cords and the speed at which the pulling force is applied can also be factors.

[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 the armband 104 by the first end 108 of the 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 opening 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 opening 162, thereby securing the transducer 158 to the top layer 120 by securing the hook fasteners on the first end 108 to the loop fasteners on the top surface 134 of the top layer 120 of the armband 104. While the first end 108 of the strap 118 is here configured to secure up to three aligned transducers 158 to the armband 104, the first end 108 may be made longer or shorter to accommodate a different number of transducers 158 or other devices desired to be secured to the securement device 100. Referring now to FIG. 11 , the location and position of the first end 108 of the strap 118 is important in transducer use because the device 100, through placement of the armband 104 on the patient, allows for precise 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 crucial for accurate monitoring of life-sustaining medications 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 with 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 noted above with device 100, which is critical for proper hemodynamic monitoring after surgery 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. Essentially, the medical line strain relief securement device 100 is a strain relief device and system that 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 in the patient's arm rather than to the IV line's insertion site into the patient, preventing painful line pulling and dangerous disconnection at the patient's insertion site. An example of this is shown 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 a 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 securement 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 constantly applies a compressive gripping force to the line 222, but the patient does not feel it. That is, the 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 armband 104 that encircles the patient's arm, ensuring that the device 100 is always ready to protect against a drag or pull. That is, the compressive load on the fixation body 102 is independent of (and can be independently adjusted from) the force used to tighten the armband 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 oval shape, promoting an even distribution of the compressive load on the fixed lines 222 around the circumference of each line 222 and 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, transferred to the armband 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 armband 104.

[0033] 12A and 12B, perspective views of another alternative embodiment of the present invention are shown in open and closed (or compressed) positions. 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 and lower layers 120, 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 that form 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 securing flange 204. The securing strap 202 further includes at least one aperture 210 formed therethrough and configured to be secured over the protrusion 208, which substantially corresponds to a hook feature for retaining the aperture 210. By securing different apertures 210, the tension applied to the securing body 200 can be varied, with apertures 210 formed closer to where the securing strap 202 is coupled to the base 212 creating more tension on the securing body 200 and apertures 210 formed in the securing strap 202 further from the base 212 creating less tension on the securing body 202. Such an embodiment allows a single line to be removed or adjusted at a particular securing body 200 when multiple securing bodies 200 are disposed on a single armband 104 without affecting the tension of any adjacent securing bodies 200 or the lines to which they are secured. In the open position, the line can 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 securement strap 202 overlapping the securement flange and terminus 206, thereby placing the opening 210 of the strap 202 over the protrusion 208 of the terminus 206, thereby tensioning 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 in 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 (first protrusion 130 or second protrusion 132 is not shown, and the retainer strap 106 is shown 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 channel 142 from being pulled in a straight line out of the gripping channel 142 and groove 144, which would be the path of least resistance for a force vector 218 or 220 in that direction. Because force vectors are typically linear and pull from a fixed location and position, the curved flange 150 and groove 144 configuration significantly reduces the likelihood of a straight line pull (whether the groove is vertical or angled). The curved or zigzag shape of the groove 144 provides a secondary defense against pulling on a straight line 222 coming straight out of the retainer 102 by providing a "pinching" effect and friction on the line, keeping it in the correct position when 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-shedding capacity in the event of a large line pull. After such a line pull, the armband should be inspected to ensure the line is returned to the correct gripping path.

[0035] A method of using the securement device 100 involves first configuring the device 100, which has at least one groove 144, at least one flange 150, a first end 114, a second end 116, and a securement strap 106 around the securement body, so that each groove 144 in the securement body 102 faces upward or toward the sky. Next, the medical tubing, IV line, and / or cord is inserted into the gripping channel 142 of the securement body 102 that most closely matches the size of the line diameter (device 100 is in the open position). Next, the securement strap 106 is fastened and tightened, bringing each flange 150 into contact with the adjacent flange 150 or the second end 116 (device 100 is in the 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 as 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] While the present invention has been described above with reference to specific embodiments, it should be understood that the 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 these are intended to be encompassed by both this disclosure and the appended claims. Rather, it is intended that the scope of the present invention 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 those of ordinary skill in the art, such technology encompasses technology that is obvious or known to those of ordinary skill in the art, now or at any time in the future.

Claims

1. A fixing band and a fixation body including a top surface, a bottom surface, a first side surface, and a second side surface, the fixation body being attached to the fixation band and configured to fix at least a portion of at least one medical tube, line, or cord; a securing strap contacting the top surface, the bottom surface, the first side surface, and the second side surface of the retainer body, the securing strap applying increasing tension to the retainer body as the securing strap is tightened around the retainer body; Equipped with the top surface, the bottom surface, the first side surface, and the second side surface are parallel to a length of the portion of the at least one medical tubing, line, or cord, and when the fixator is under tension by the fixation strap, they deform around the portion of the at least one medical tubing, line, or cord to apply a compressive load to the portion of the at least one medical tubing, line, or cord, thereby securing the portion against movement due to a pulling force; Fixtures.

2. 10. The securement device of claim 1, wherein the securement body is configured to provide a substantially uniform compressive load around the circumference of the secured portion of the at least one medical tubing, line, or cord when under tension.

3. 10. The securement device of claim 1, wherein the securement body is configured to absorb and transmit force applied to the secured portion of the at least one medical tubing, line, or cord to the securement band when under tension.

4. The fixation device of claim 1 further comprising a strap extending through the fixation body.

5. 2. The fixation device of claim 1, wherein the fixation band further comprises an upper layer having an opening formed therethrough and a lower layer, a portion of the fixation body being secured between the upper layer and the lower layer, and the fixation strap being slidable along the bottom surface of the fixation body.

6. The fixation device of claim 5 , wherein the fixation body extends partially through the opening in the upper layer.

7. 6. The securement device of claim 5, wherein the bottom layer is made of USP Class VI (United States Pharmacopoeia Class 6) medical grade material.

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

9. A fixing band and a fixture attached to the retention band, the fixture including a top surface, a bottom surface, a first side surface, and a second side surface, the fixture further including at least one gripping passage formed therethrough, the at least one gripping passage configured to hold at least one medical tubing, line, or cord; a fastening strap contacting the top surface, the bottom surface, the first side surface, and the second side surface of the fixture, the fastening strap configured to apply increasing tension to the fixture as the fastening strap is tightened; Equipped with the retainer is configured, when under tension, to deform to create a substantially uniform hoop stress around the at least one gripping passageway to prevent movement of at least a portion of the at least one medical tubing, line, or cord retained by the retainer within the retainer under a pulling force of up to 20 lbf. Fixtures.

10. The fixed body is a single base; a strap opening formed through the base and configured to cooperate with a strap; at least one flange coupled to the base and the at least one gripping channel; At least one end Further comprising: the at least one flange and the second flange or the at least one terminal end define a groove connected to the at least one gripping passage; 10. The fixation device of claim 9.

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

12. The fixed body is a first protrusion extending from the base; a second protrusion 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.

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

14. 14. The fixation device of claim 13, 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 the patient's arm.

15. The fixation device according to claim 9 , wherein the fixation body is made of an adhesive elastomer.

16. The fixation device of claim 9, further comprising a strap attached to the fixation band and configured to secure the fixation band around a fixation structure.

17. The fixation device of claim 9 , wherein the fixation strap lies around the fixation body in a plane perpendicular to the at least one gripping path.

18. 1. A method for securing a medical tubing, line, or cord to a securement device, comprising: securing a securing band to a fixed structure, the securing band including a securing strap and a securing body having at least one gripping passage, each gripping passage being defined by either two flanges or one flange and one end, each of the two flanges or the one flange and one end including an upper surface; inserting at least a portion of the medical tubing, line, or cord into the at least one gripping passage; tightening the fixation strap around the fixation body so that the fixation strap contacts the two flanges and the top surface of either the one flange or the one end, thereby deforming the fixation body to create a hoop stress around the at least one gripping passage and prevent movement of at least the portion of the medical tubing, line, or cord; 1. A method for securing a medical tube, line, or cord to a securement device, comprising:

19. 20. The method of claim 18, wherein the diameter of the at least one gripping passage substantially matches the outer diameter of the medical tubing, line, or cord.

20. 20. The method of claim 18, wherein the portion of the fixator forming the at least one gripping passage is compressed around a circumference of the medical tubing, line, or cord.

21. The method of claim 18 , wherein the retainer further comprises a strap.

22. a securing band configured to be removably attached to a fixed structure; a fixation body attached to the fixation band and configured to secure at least one medical tubing, line, or cord, the fixation body further comprising a surface defining a periphery of the fixation body; a fastening strap contacting the surface around the entire periphery of the fastener; Equipped with the fixation body is configured to separate the at least one medical tubing, line, or cord into a load side and a fixation side when under tension by the fixation strap, and the fixation body is configured to transmit a pulling force applied two or more times to the load side of the at least one medical tubing, line, or cord to the fixation body and the fixation structure, rather than to the fixation side of the at least one medical tubing, line, or cord. Fixtures.

23. 23. The fixation device of claim 22, wherein the fixation band is tightenable and adjustable independently of the fixation strap.

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

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