WO2023148728A1 - Medical line anchoring device - Google Patents

Medical line anchoring device Download PDF

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Publication number
WO2023148728A1
WO2023148728A1 PCT/IL2023/050107 IL2023050107W WO2023148728A1 WO 2023148728 A1 WO2023148728 A1 WO 2023148728A1 IL 2023050107 W IL2023050107 W IL 2023050107W WO 2023148728 A1 WO2023148728 A1 WO 2023148728A1
Authority
WO
WIPO (PCT)
Prior art keywords
band
locking pin
tail section
channels
channel
Prior art date
Application number
PCT/IL2023/050107
Other languages
French (fr)
Inventor
Asaf RABIN
Ofir Amir
Tamar SHEINSON
Original Assignee
Roshouz Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roshouz Ltd. filed Critical Roshouz Ltd.
Publication of WO2023148728A1 publication Critical patent/WO2023148728A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • AHUMAN NECESSITIES
    • A44HABERDASHERY; JEWELLERY
    • A44CPERSONAL ADORNMENTS, e.g. JEWELLERY; COINS
    • A44C5/00Bracelets; Wrist-watch straps; Fastenings for bracelets or wrist-watch straps
    • A44C5/0007Bracelets specially adapted for other functions or with means for attaching other articles
    • AHUMAN NECESSITIES
    • A44HABERDASHERY; JEWELLERY
    • A44CPERSONAL ADORNMENTS, e.g. JEWELLERY; COINS
    • A44C5/00Bracelets; Wrist-watch straps; Fastenings for bracelets or wrist-watch straps
    • A44C5/18Fasteners for straps, chains or the like
    • A44C5/20Fasteners for straps, chains or the like for open straps, chains or the like
    • A44C5/2071Fasteners for straps, chains or the like for open straps, chains or the like with the two ends of the strap or chain overlapping each other and fastened by an action perpendicularly to the main plane of these two ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0206Holding devices, e.g. on the body where the catheter is secured by using devices worn by the patient, e.g. belts or harnesses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0213Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/024Holding devices, e.g. on the body having a clip or clamp system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/028Holding devices, e.g. on the body having a mainly rigid support structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/08Supports for equipment
    • A61M2209/088Supports for equipment on the body

Definitions

  • the invention relates to the field of devices for anchoring and securement of medical lines and tubing.
  • Medical treatment of a subject often includes insertion of medical lines and tubing into the subject's body, for introduction or withdrawal of fluids, or for the delivery of medication and/or nutrition.
  • medical monitoring and similar devices such as ECG monitors, require the attachment of electrodes or sensors to the subject’s body, which are then connected through electrical leads extending from the electrode or sensor to an ambulatory or bedside monitoring.
  • the medical lines and/or leads need to be secured to the subject’s body, to prevent entanglement and/or accidental disconnection of the lines/leads, e.g., due to subject movement, transfer, and/or position changes.
  • the possible consequences of tubing or leads disconnection can be severe, and include bleeding, discharge of bodily fluids or medication, and/or loss of monitoring signal.
  • a device comprising an elongate flexible band having a top surface and a bottom surface, the band comprising: (i) a proximal opening at a proximal end of the band, (ii) a first locking pin disposed distally of the proximal opening, (iii) a channel portion disposed distally of the first locking pin, the channel portion comprising at least one channel configured to releasably receive at least one medical line therein, (iv) a second locking pin disposed distally of the channel portion, and (v) a tail section extending distally from the second locking pin and comprising a series of spacedapart through-holes arranged lengthwise thereon, wherein the through-holes are each dimensioned to engage one of the first and second locking pins.
  • the band is dimensioned for closing around a body part of a subject, by bringing the tail end around the body part towards said proximal end and advancing a specified portion of the tail section in a tightening direction through the proximal opening, to achieve a desired degree of tightening of the band around aid body part.
  • the tail section comprises at least one side edge comprising a series of grip elements selected from the group consisting of: scalloping, prongs, barbs, grooves, channels, bumps, teeth, notches, serrations, surface roughening, and high-friction areas.
  • the specified portion of the tail section is advanced through the proximal opening
  • the series of grip elements are configured to engage with an inside perimeter edge of the proximal opening, so as to resist a retraction of the specified portion of the tail section through the proximal opening in a loosening direction.
  • the first locking pin upon advancing the specified portion of the tail section through the proximal opening, is configured to engage a nearest first one of the through-holes in the tail section.
  • the first locking pin comprises a tooth-like projection oriented in the proximal direction.
  • the toothlike projection oriented in the proximal direction is configured to resist any tensional force applied to the specified portion of the tail section in the tightening direction, so as to maintain the desired degree of tightening of the band around the body part.
  • the second locking pin comprises a tooth-like projection oriented in the distal direction.
  • the specified portion of the tail section is configured to extend over the channel portion, such that the second locking pin engages a second one of the through- holes, wherein the tooth-like projection oriented in the distal direction is configured to resist any tensional force applied to the specified portion of the tail section in the loosening direction.
  • each of the first and second locking pins comprises a first tooth-like projection oriented in the proximal direction, and a second tooth-like projection oriented in the distal direction.
  • each of the channels defines a through -passageway that substantially transverses and extends across a width dimension of the channel portion.
  • the medical line is selected from the group consisting of: tubing, hoses, cannulae, catheters, conduits, power cables, data cables, electrical leads, and electrical wires.
  • each of the channels is configured to engage the at least one medical line about at least a part of its circumferential surface.
  • each of the channels has a cross-sectional shape selected from the group consisting of: circular, oval, square, rectangular, and polygonal.
  • each of the channels has a cross-section that is dimensioned such that a maximal circle inscribed within the cross-section has a diameter of between 2- 15mm.
  • each of the channels is formed with an upper rim comprising a notch-like insertion slot comprising a pair of opposing lips of the upper rim, which define a gap having a specified width.
  • the opposing lips may be resiliently deformed to widen the gap to permit an insertion of the at least one medical line through the insertion slot and into the through-passageway of the channel, wherein the opposing lips are configured to resiliently return to their original position upon the insertion.
  • the insertion slot when in the original position, is configured to resist extrication of the at least one medical line from the channel.
  • the gap is wider in at least one of its ends.
  • each of the channels is numbered.
  • the device further comprises a fastening loop located distally of the second locking pin and proximally of the tail section, wherein, upon the engaging by the second locking pin of the second one of the through-holes, the tail end is further configured to be threaded and advanced in the tightening direction through the fastening loop.
  • the fastening loop comprises a concave area disposed underneath the fastening loop, wherein the concave area is configured to facilitate the threading and advancing of the tail end in the tightening direction.
  • the concave area defines a through-aperture in the band, wherein the through aperture comprises a sloping tongue at a distal end thereof.
  • the band is made of one or more of: rubber, thermoplastic elastomer (TPE), silicone rubber, another polymer, and metal. [0031] In some embodiments, at least the tail section is stretchable.
  • At least a portion of the band comprises surface features selected from the group consisting of: ridges, divots, dimples, frictional elements, grooves, channels, bumps, surface roughening, and high-friction areas.
  • the bottom surface of the band comprises surface features defining diagonal ridges.
  • a method comprising: providing a device comprising an elongate flexible band having a top surface and a bottom surface, the band comprising: (i) a proximal opening at a proximal end of the band, (ii) a first locking pin disposed distally of the proximal opening, (iii) a channel portion disposed distally of the first locking pin, the channel portion comprising at least one channel configured to releasably receive at least one medical line therein, (iv) a second locking pin disposed distally of the channel portion, and (v) a tail section extending distally from the second locking pin and comprising a series of spaced-apart through-holes arranged lengthwise thereon, wherein the through-holes are each dimensioned to engage one of the first and second locking pins; closing the band around the body part of the subject, by bringing the tail end around the body part towards said proximal end, and advancing
  • the tail section comprises at least one side edge comprising a series of grip elements selected from the group consisting of: scalloping, prongs, barbs, grooves, channels, bumps, teeth, notches, serrations, surface roughening, and high-friction areas.
  • the series of grip elements are configured to engage with an inside perimeter edge of the proximal opening, so as to resist a retraction of the specified portion of the tail section through the proximal opening in a loosening direction.
  • the first locking pin comprises a tooth-like projection oriented in the proximal direction.
  • the toothlike projection oriented in the proximal direction is configured to resist any tensional force applied to the specified portion of the tail section in the tightening direction, so as to maintain the desired degree of tightening of the band around the body part.
  • the second locking pin comprises a tooth-like projection oriented in the distal direction.
  • the tooth- like projection oriented in the distal direction is configured to resist any tensional force applied to the specified portion of the tail section in the loosening direction.
  • each of the first and second locking pins comprises a first tooth-like projection oriented in the proximal direction, and a second tooth-like projection oriented in the distal direction.
  • each of the channels defines a through-passageway that substantially transverses and extends across a width dimension of the channel portion.
  • the at least one medical line is selected from the group consisting of: tubing, hoses, cannulae, catheters, conduits, power cables, data cables, electrical leads, and electrical wires.
  • each of the channels is configured to engage the at least one medical line about at least a part of its circumferential surface.
  • each of the channels has a cross-sectional shape selected from the group consisting of: circular, oval, square, rectangular, and polygonal. [0046] In some embodiments, each of the channels has a cross-section that is dimensioned such that a maximal circle inscribed within the cross-section has a diameter of between 2- 15mm.
  • each of the channels is formed with an upper rim comprising a notch-like insertion slot comprising a pair of opposing lips of the upper rim, which define a gap having a specified width.
  • the opposing lips may be resiliently deformed to widen the gap to permit an insertion of the at least one medical line through the insertion slot and into the through-passageway of the channel, wherein the opposing lips are configured to resiliently return to their original position upon the insertion.
  • the insertion slot when in the original position, is configured to resist extrication of the at least one medical line from the channel.
  • the gap is wider in at least one of its ends.
  • each of the at least one channels is numbered.
  • the device further comprises a fastening loop located distally of the second locking pin and proximally of the tail section, wherein the method further comprises threading and advancing the tail end in the tightening direction through the fastening loop.
  • the fastening loop comprises a concave area disposed underneath the fastening loop, wherein the concave area is configured to facilitate the threading and advancing of the tail end in the tightening direction.
  • the concave area defines a through-aperture in the band, wherein the through aperture comprises a sloping tongue at a distal end thereof.
  • the band is made of one or more of: rubber, thermoplastic elastomer (TPE), silicone rubber, another polymer, and metal.
  • TPE thermoplastic elastomer
  • silicone rubber another polymer
  • metal metal
  • At least the tail section is stretchable.
  • at least a portion of the band comprises surface features selected from the group consisting of: ridges, divots, dimples, frictional elements, grooves, channels, bumps, surface roughening, and high-friction areas.
  • the bottom surface of the band comprises surface features defining diagonal ridges.
  • Fig. 1 is a perspective view of a device of the present disclosure, according to some embodiments of the present disclosure.
  • Fig. 2 is a top view of a device of the present disclosure, according to some embodiments of the present disclosure.
  • Fig. 3 is a bottom view of a device of the present disclosure, according to some embodiments of the present disclosure.
  • Fig. 4 is a side view of a device of the present disclosure, according to some embodiments of the present disclosure.
  • FIG. 5A-5B are flowcharts of the functional steps in a method for application to the human body of a device for anchoring, securing, and/or stabilizing of medical lines to a desired location on a body of a subject, according to some embodiments of the present disclosure
  • Fig. 6 illustrates the application of a device of the present disclosure to a body part of a subject, according to some embodiments of the present disclosure
  • Figs. 7A-7C illustrate the steps in the process for anchoring and securing one or more medical lines within respective medical line channels, according to some embodiments of the present disclosure
  • Figs. 8A-8C are, respectively, enlarged perspective, top, and side views of a first locking zone, a channel zone, and a second locking zone of a device of the present disclosure, according to some embodiments of the present disclosure;
  • FIG. 9 is an enlarged perspective view of a second locking zone of a device of the present disclosure, according to some embodiments of the present disclosure.
  • Figs. 10A-10B show enlarged detail of locking pins of a device of the present disclosure, according to some embodiments of the present disclosure
  • FIGs. 11A-11B are additional perspectives views of a device of the present disclosure, according to some embodiments of the present disclosure.
  • Fig. 12 shows a detail of a bottom surface of a device of the present disclosure, according to some embodiments of the present disclosure.
  • devices and methods configured for anchoring, securing, and/or stabilizing medical lines and/or leads to a desired location on a body of a subject, for use during administration of therapy and/or monitoring of physiological parameters in the subject.
  • the term ‘medical line’ refers generally to any medical lines, tubing, hoses, cannulae, catheters, sheaths, and/or similar conduits used, e.g., in intravenous (IV) therapy; for purposes of fluid replacement, drainage, and/or withdrawal; and/or to administer medications, nutrients, volume expanders, blood-based products, and/or other fluids; and/or intraarterial (IA) line for blood pressure continuous measurement, blood withdrawal, and/or intraarterial therapy (catheterization, ECMO, etc.).
  • IV intravenous
  • IA intraarterial
  • medical line as used herein further encompasses any power or data cables, leads, wires, and/or similar electrical lines used to transmit electrical power, electrical signals, data, and/or any similar transmission from a body site to a remote monitoring unit.
  • the present disclosure will discuss extensively applications of the present device in the context of IV therapy involving an IV catheter. However, as will be apparent to those skilled in the art, the present disclosure is equally effective with respect to any other types of medical lines and/or signal leads, which require securement at a desired bodily site.
  • lines are typically secured or stabilized to the subject's body in a way which assumes any tensional force applied to the line at the securement location, and prevents unwanted movement or displacement forces to be transmitted further to the insertion site to the body. Stabilizing the line thus prevents the line from getting pulled, snagged, bent, twisted, or tangled; prevents the line from inadvertently causing tensional stress to the catheter and surrounding area of the catheter insertion site; and relieves the subject or healthcare professional from the burden of having to hold the line during administration of liquids.
  • the present disclosure provides for a medical line anchoring device which is configured to secure one or more medical lines at a desired site on a subject’s body, in a way which ensures that the one or more lines will not be displaced, pulled out, or otherwise disconnected from the insertion site.
  • the present device is simple in design, easy to produce, its application to the subject is straightforward, and it can be re-used multiple times, thus reducing potential waste and promoting sustainability.
  • the present device is configured to be fastened or closed around a circumference of a body part of a subject, and can be applied with an adjustable degree of fastening or tightness, to prevent any long-term discomfort to the subject.
  • one or more medical lines of various types and sizes may be inserted and securely anchored, in a way which is independent of, and does not affect or disturb, the fastening of the device around the body part.
  • any addition, removal, and/or replacement of one or more medical lines within the fastened device does not involve any opening, loosening, tightening, and/or retightening of the fastened device around the body part.
  • the device maintains a steady degree of fastening around the body part of the subject throughout the duration of the therapy (which may involve multiple occasions of adding, removing, and/or replacing individual medical lines), and thus avoids even momentary discomfort or annoyance to the subject.
  • a potential advantage of the present device is, therefore, in that it provides for fast, easy and secure addition, removal and/or replacement and of multiple individual medical lines to the present device, while it is fastened around a body part, without the need to loosen or remove the device, without disturbing any other of anchored lines, and without causing any pain or discomfort to the subject.
  • the present device provides for visual organization of multiple medical lines being used at once with respect to a subject, such that the multiple lines are presented visually in a well-ordered and easy-to-distinguish manner, thus reducing the potential for errors in the administration of therapy by medical practitioners.
  • FIG. 1 is a perspective view of an exemplary device for anchoring, securing, and/or stabilizing of medical lines to a desired location on a body of a subject, according to some embodiments of the present disclosure.
  • Figs. 2, 3 and 4 are, respectively, a top view, a bottom view, and a side view of band 100 shown in perspective view in Fig. 1.
  • the exemplary device of the present disclosure comprises a band 100 comprising a flexible, elongate strip of material, e.g., a strap, a band, a sleeve, or the like, configured to surroundingly -engage (i.e., close or fasten around a circumference of) a body part of a subject.
  • band 100 may be dimensioned to close around a circumference of a body part or a bodily region of a subject, e.g., an arm, a forearm, a wrist, a leg, a thigh, an ankle, a limb, a neck, a head, a torso, etc.
  • band 100 has a length of between, e.g., 90-660mm. In some embodiments, band 100 has a width of between, e.g., 10-25mm.
  • band 100 generally defines a flat elongate strap or band having a top surface 102 and a bottom surface 104, wherein bottom surface 104 is a skincontacting surface of band 100.
  • top surface 102 becomes an outer-facing surface of band 100
  • bottom surface 104 becomes an inner-facing surface of band 100.
  • band 100 comprises one or more of the following sections, e.g.:
  • a setting zone A extending from tail end 106 proximally, in the direction of proximal end 108, and comprising an array or a series of through holes 110, spacedapart lengthwise at predetermined intervals along at least a portion of a length of setting zone A.
  • At least a portion of setting zone A comprises at least one side edge featuring a scalloped, toothed, notched, jagged, serrated and/or otherwise a saw-like design, e.g., one or more of side edges 112; a first locking zone LI extending from proximal end 108 distally, in the direction of tail end 106, and comprising, e.g., a proximal opening 124 and a first locking pin 120; a second locking zone L2 extending from a proximal end of setting zone A proximally, in the direction of proximal end 108, and comprising, e.g., a second locking pin 122, a fastening loop 126, and a concave area 128 underneath fastening loop 126; and a channel zone B extending between the first and second locking zones LI and L2, and comprising one or more channels 130, each configured to receive and anchor a medical line therein.
  • channel zone B comprises,
  • FIGs. 5A-5B are flowcharts of the functional steps in a method 500 for application to the human body of a device (such as band 100 shown in Figs. 1-4) for anchoring, securing, and/or stabilizing of medical lines to a desired location on a body of a subject, according to some embodiments of the present disclosure.
  • Method 500 begins in step 502, wherein, as illustrated in Fig. 6, band 100 may be positioned in proximity to a desired body site, e.g., an arm, a forearm, a wrist, a leg, a thigh, an ankle, a limb, a neck, a head, a torso, to be closed and fastened around it.
  • a desired body site e.g., an arm, a forearm, a wrist, a leg, a thigh, an ankle, a limb, a neck, a head, a torso
  • body part 140 e.g., by bringing tail end 106 around body part 140 (e.g., a wrist in this case), so as to close around and surroundingly engage body part 140.
  • tail end 106 may then be negotiated or threaded through proximal opening 124 located at proximal end 108, and advanced therethrough. In some embodiments, tail end 106, once threaded through opening 124, may be advanced or pulled through opening 124, such that an overlapping portion of band 100 extends from proximal end 108. In some embodiments, an extent to which tail end 106 is advanced and extends through opening 124 determines a degree of tightness of band 100 around body part 140.
  • tail end 106 may also be pulled back against an outer lip of opening 124, so as to gain a mechanical advantage in establishing a degree of fastening or tightness of band 100 around body part 140, similar to the way a belt might be tightened.
  • this method of tightening using the mechanical advantage may be used to produce momentary greater tightness, e.g., to facilitate insertion of a needle to a peripheral vein, which tightness may then be released and set a desired level.
  • side edges 112 are configured to cooperate with an inside perimeter edge of opening 124, to provide for mechanical and/or frictional engagement between side edges 112 and the internal perimeter edge of opening 124, which works to resist the retraction back of the portion of setting zone A advanced through opening 124, other than through the intentional application of force calculated to retract setting zone A from opening 124.
  • side edges 112 may comprise a series of grip and/or frictional elements along at least a portion of a length of setting zone A, such as scalloping, prongs, barbs, grooves, channels, bumps, teeth, notches, serration, surface roughening, high-friction pads, and/or any other suitable grip and/or frictional element.
  • side edges 112 cooperate with opening 124 to retain the portion of setting zone A advanced through opening 124 and to maintain the desired degree of fastening or tightness of band 100 around the body part.
  • an overlapping portion of a length of setting zone A which has been brought around the body part, advanced through opening 124, and extends beyond opening 124 and towards zones B and L2, may then be used to anchor and secure one or more medical lines within respective channels 130 in channel zone B, as shall be detailed further below.
  • FIGs. 7A-7C illustrate the functional steps in the process for anchoring and securing one or more medical lines within respective channels 130 in channel zone B.
  • step 504 an overlapping portion 106a of setting zone A, which extends from opening 124 in a tightening direction marked by arrow X, may be secured to first locking pin 120 within first locking zone LI, e.g., by removably engaging an optimum hole 110 (for example, the nearest one of holes 110 when band 100 is optimally fitted to body part 140) with locking pin 120.
  • an optimum hole 110 for example, the nearest one of holes 110 when band 100 is optimally fitted to body part 140
  • engaging the selected hole 110 with first locking pin 120 may be achieved by pressing the area surrounding the selected hole 110 directly onto locking pin 120, thereby causing the selected hole 110 to elastically expand and receive locking pin 120 therein. Additionally or alternatively, overlapping portion 106a may be stretched to enlarge and/or elongate the selected hole 110, so as to slip the selected hole 110 over locking pin 120.
  • locking pin 120 comprises a tooth-like projection 120a oriented in the proximal direction. By expanding, enlarging, and/or elongating the selected hole 110, the selected hole 110 may be slipped over locking pin 120 past the area comprising projection 120a. Once reaching the area below projection 120a, the selected hole 110 may return to its original dimensions, and thus be prevented from being dislodged unintentionally from locking pin 120.
  • band 100 is fastened and closed around the body part to a desired degree of fastening or tightness, and side edges 112 and opening 124 cooperate to retain the portion of setting zone A advanced through opening 124 and resist its retraction back through opening 124.
  • first locking pin 120 and projection 120a tends to prevent the selected hole 110 from being dislodged due to any tensional force applied to overlapping portion 106a or to tail end 106 in the tightening direction, e.g., in the direction of arrow X, which otherwise would work to further tighten band 100 around body part 140.
  • one or more medical lines 142 may be inserted into respective channels 130.
  • Each of channels 130 is dimensioned and configured to releasably receive one medical line 142 therein.
  • Figs. 8A-8C are, respectively, enlarged perspective, top, and side views of portions LI, B, and L2 of band 100.
  • each of channels 130 defines a through passageway that substantially transverses and extends across a width dimension of channel zone B of band 100.
  • each of channels 130 is dimensioned and configured to releasably receive a respective one of a plurality of medical lines (142 in Figs. 7B-7C and 8C), and to engage the received medical line 142 about at least a part of its circumferential surface along the length of channel 130.
  • a cross-sectional shape of each channel 130 may be, e.g., circular, oval, polygonal, and/or any other suitable cross-sectional shape configured to engage a section of a medical line 142 received within channel 130 about at least a part of its circumference along the length of channel 130.
  • a cross-section dimension of each channel 130 may be configured to receive medical lines of varying sizes and diameters.
  • each channel 130 may be dimensioned such that a maximal circle inscribed within its crosssection has a diameter of between, e.g., 2-15mm.
  • each channel 130 is dimensioned to receive and securely retain therein a medical line of a specified size or a range of sizes, and to apply sufficient frictional force about at least a portion of the circumference of the received line, so as to resist the unintentional release or axial movement of the line while received within channel 130.
  • at least one of channels 130 within band 100 may be dimensioned and configured to receive two or more medical lines therein.
  • a channel zone B comprises more than one channel 130
  • all individual channels 130 may have identical cross-sectional shape and dimension.
  • two or more channels 130 within the same channel zone B may have varying cross-sectional shapes and dimensions.
  • each of channels 130 may be formed with an upper rim formed with a notch-like elastic insertion slot 130a.
  • insertion slots 130a are defined by opposing lips of a respective channel 130 defining a narrow gap therebetween.
  • the insertion slots 130a are formed of a resiliently pliable material, wherein the opposing lips of the insertion slots 130a may be resiliently deformed to widen the gap and permit the insertion of a medical line 142 therethrough and into the through-passageway of channel 130, and, once the medical line has passed through the respective insertion slot 130a, to resiliently return to their original position and close the gap above the medical line received within channel 130, and thus work to retain the medical line within the respective channel 130 and to prevent its unintentional extrication.
  • a medical line may be extricated from a channel 130 by applying an extricating force which tends to pull medical line 142 of its respective channel 130, again, by momentarily widening the respective insertion slot 130a by resiliently deforming the opposing lips of channel 130.
  • insertion slots 130a may define a gap which is not of a consistent width along its length, e.g., a gap which is wider at one or both ends, and narrows towards the middle.
  • a medical line 142 e.g., as shown in Fig 8C
  • the medical line 142 may be slipped in through insertion slot 130a and into channel 130a, wherein insertion slot may resiliently return to their original shape.
  • channels 130 may be numbered 130b, such as to facilitate the organizing and visual presentation of the medical lines 142 (shown in Fig 8C) in a well-ordered and easy-to-distinguish manner, thus reducing the potential for errors in the administration of therapy by medical practitioners.
  • overlapping portion 106a may be secured over channel zone B, by removably engaging second locking pin 122.
  • overlapping portion 106a may be pulled and stretched over channel zone B, and then secured by, e.g., removably engaging a nearest or selected one of holes 110 with locking pin 122.
  • locking pin 122 comprises a tooth-like projection 122a oriented in the distal direction.
  • the selected hole 110 may be slipped over locking pin 122 past the area comprising projection 122a. Once reaching the area below projection 122a, the selected hole 110 may return to its original dimensions, and thus be prevented from being dislodged unintentionally from locking pin 122.
  • the design of second locking pin 122 and projection 122a once removably engaged with a hole 110, tends to counter any tensional force applied to overlapping portion 106a in the loosening direction, e.g., the opposite direction to the direction of arrow X.
  • the section of overlapping portion 106a covering channel zone B e.g., between first and second locking pins 120 and 122, may be maintained at a slightly tensioned state by projections 120a and 122a, to as to securely anchor medical lines 142 in respective channels 130.
  • first and second locking pins 120, 122 and projections 120a, 122a may cooperate to retain a degree of tensioning in the section of overlapping portion 106a extending between first and second locking pins 120, 122.
  • the operation of removably engaging a respective hole 110 of overlapping portion 106 with second locking pin 122 may involve slightly stretching overlapping portion 106 (which is already removably engaged with first locking pin 120, providing a counter force to the stretching action), e.g., by pulling on tail end 106, in the direction of arrow X.
  • the stretching action does not affect the tightening level of band 100 around body part 140, because the stretching force is countered by the design of first locking pin 120.
  • tail end 106 may be threaded and advanced through fastening loop 126, to secure any dangling remainder of overlapping portion 106a, to prevent the potential risk of unintentional disengagement of overlapping portion 106 from second locking pin 122.
  • a dip, a concavity, or a through-aperture area 128 may be provided in locking zone L2 of band 100, generally underneath fastening loop 126.
  • Concave area 128 may comprise a sloping tongue 128a at a distal end thereof, which may be disposed at a bias relative to a transverse axis defined by band 100.
  • Tongue 128a may be configured to facilitate the threading and advancing of tail end 106 through fastening loop 126, so as to prevent tail 106 from being trapped or wedged underneath fastening loop 126 as it is being advanced therethrough, and urge tail end 106 upwardly and out from under fastening loop 126.
  • one or more of medical lines 142 may be added, removed, and/or replaced within channel zone B.
  • overlapping portion 106a may be retracted back through fastening loop 126.
  • step 514 the respective hole 110 is disengaged from second locking pin 122.
  • overlapping portion 106a may be lifted or peeled back (to a position similar to that shown in Fig. 7A) to expose channel zone B and channels 130.
  • One or more medical lines 142 (shown in Figs. 7B-7C and 8C) may be added, removed, and/or replaced, as detailed with reference to step 504. Then steps 506-508 may be repeated to secure channel zone B again.
  • step 518 similarly to step 508, overlapping portion 106a may be re-secured over channel zone B, by removably engaging second locking pin 122.
  • tail end 106 may be re-threaded and advanced through fastening loop 126, to secure any dangling remainder of overlapping portion 106a.
  • Figs. 10A-10B show locking pins 120, 122 in enlarged detail.
  • each locking pin 120, 122 has a single tooth-like projection 120a, 122a, respectively. Projection 120a is oriented in the proximal direction, while projection 122a is oriented in the distal direction.
  • each locking pin 120, 122 has two tooth-like projections 120a- 120b, and 122a-122b, respectively. Projections 120a and 122b are oriented in the proximal direction, while projections 120b and 122a are oriented in the distal direction.
  • FIGs. 11A-11B show additional perspective views of an exemplary device for anchoring, securing, and/or stabilizing of medical lines to a desired location on a body of a subject, according to some embodiments of the present disclosure.
  • band 100 may be made of any suitable material, comprising for example, rubber, thermoplastic elastomer (TPE), silicone rubber, plastic, any other polymer known in the art, or metal, and is preferably constructed to provide nonslip characteristics on its surface to aid in gripping.
  • One or more portions of band 100 may have surface features, e.g. ridges, divots, dimples, frictional elements, grooves, channels, bumps, surface roughening, and/or high-friction areas, and the like, to aid in gripping.
  • a bottom surface 104 may have surface features such as ridges 146, which may run diagonally relative to a transverse axis defined by band 100, to aid in expelling moisture or providing ventilation, in areas prone to accumulation of moisture, e.g., due to perspiration by the subject.
  • Band 100 may be made of a single piece of polymeric material, e.g., by molding or additive manufacturing methods (e.g., 3D printing). Alternatively, band 100 may comprise several polymeric materials having different mechanical properties adapted to the constraints that the different parts of the device are subjected to. For example, it is possible to use a more rigid polymer for the first and second locking pins 120, 122, and a more pliable polymer to construct channels 130.
  • band 100 may be integrally formed, e.g., as a unitary element made of a single material, e.g., using an injection process.
  • band 100 may comprise two or more different materials in different parts thereof, or different varieties of the same material in different parts thereof, e.g., having varying mechanical properties, such as pliability, rigidity, elasticity, stretchability, etc.
  • band 100 may be produced using an over-molding process enabling materials of different mechanical properties to be over-molded and/or assembled in order to mold various parts of band 100 (e.g., proximal opening 124, first and second locking pins 120 and 122, channel zone B, channels 130, fastening loop 126, and/or concave area 128 and tongue 128a) using materials having different mechanical properties.
  • certain parts, e.g., channels 130 and/or other parts may be separately formed, e.g., a inserts to be attached to band 100.
  • channels 130 may be integrally formed with band 100, however, channels 130 may be configured to receive replaceable inserts designed to receive and secure medical lines of varying shapes, sizes, and diameters.
  • channel zone B may be an interchangeable channel zone, wherein band 100 may be configured to allow attachment and/or replacement of a separately-formed channel zone B therein.
  • a channel zone B may be selected from a variety of different channel zones, each comprising, e.g., a different number of channels 130, which may be of different cross-sectional shapes and/or dimensions. The selected channel zone B may then be attached to the band 100 at the designated space allocated within band 100, to serve as the channel zone B.
  • band 100 may be produced in a variety of colors, wherein a specified color (e.g., red, blue, or yellow) may be associated with a particular medical center, type of treatment, or subject pathology.
  • a specified color e.g., red, blue, or yellow
  • band 100 may be configured for linking with one or more other devices 100, e.g., to produce a longer version of band 100, e.g., which can fit body parts of a larger diameter, e.g., neck, head, torso, etc.
  • band 100 of the present disclosure may comprise one or more integrated sensors which may comprise characteristics of any of a variety of different types of sensors, signals from which may be analyzed to ascertain a health status of a subject.
  • sensors may, for example, comprise physiological sensors that operate to monitor physiological characteristics of a subject, e.g.: heart monitoring sensors, heart -rate monitoring sensors, electrocardiogram (ECG) sensors, body temperature sensors, breath- rate/respiration sensors (e.g., pressure-based and/or acoustic-based), skin conductivity sensors, oxygen saturation sensors, blood perfusion sensors, skin humidity sensors, electroencephalograph (EEG) sensors, and/or muscle activity sensors.
  • ECG electrocardiogram
  • body temperature sensors e.g., body temperature sensors
  • breath- rate/respiration sensors e.g., pressure-based and/or acoustic-based
  • skin conductivity sensors e.g., oxygen saturation sensors, blood perfusion sensors, skin humidity sensors, electroencephalograph (EEG) sensors, and/or muscle activity sensors
  • such sensors may also comprise non -physiological sensors that operate to monitor characteristics other than physiological characteristics of the subject.
  • Such non- physiological sensors may, for example, comprise environmental sensors that operate to monitor aspects of the environment in which a subject is performing a task.
  • environmental sensors may comprise: air temperature sensors, air speed sensors, humidity sensors, air oxygen level sensors, barometric pressure sensors, altitude/elevation sensors, precipitation sensors, light sensors, movement sensors, multi - axes accelerometers, location sensors/systems (e.g., global positioning system (GPS) sensors, ranging and direction sensors, terrestrial triangulation sensors/systems (e.g., cellular communication system based, premises based, campus based, etc.)), time sensors (e.g., time change and/or absolute time), orientation sensors, etc.
  • GPS global positioning system
  • time sensors e.g., time change and/or absolute time
  • Such non -physiological sensors may also, for example, comprise situational sensors that operate to monitor characteristics of a physical situation (e.g., a task or activity) in which the subject is engaged.
  • situation (or activity) sensors may, for example and without limitation, comprise: weight sensors, impact sensors, force sensors, pressure sensors, accelerometers, inclinometers, motion sensors, speed and/or velocity sensors, etc.
  • band 100 may comprise an identification module, e.g., a radio-frequency ID (RFID) or a near-field communication (NFC) tags, which may be used to identify a subject with respect to whom band 100 in being used.
  • RFID radio-frequency ID
  • NFC near-field communication
  • band 100 may comprise a communications module via which band 100 may communicate with other systems and/or other devices utilizing wired and/or wireless communication, e.g., any short- or long-range wireless communications protocol, such as wi-fi, Bluetooth, ZigBee, cellular communications, any other radiofrequency protocol, etc.
  • any short- or long-range wireless communications protocol such as wi-fi, Bluetooth, ZigBee, cellular communications, any other radiofrequency protocol, etc.

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Abstract

A device comprising: an elongate flexible band having a top surface and a bottom surface, the band comprising: (i) a proximal opening at a proximal end of the band, (ii) a first locking pin disposed distally of the proximal opening, (iii) a channel portion disposed distally of the first locking pin, the channel portion comprising at least one channel configured to releasably receive at least one medical line therein, (iv) a second locking pin disposed distally of the channel portion, and (v) a tail section extending distally from the second locking pin and comprising a series of spaced-apart through-holes arranged lengthwise thereon, wherein the through-holes are dimensioned to engage the first and second locking pins.

Description

MEDICAL LINE ANCHORING DEVICE
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of priority of U.S. Provisional Patent Application No. 63/305,303, filed February 1, 2022, entitled “MEDICAL LINE ANCHORING DEVICE,” the contents of which are incorporated herein by reference in their entirety.
FIELD OF THE INVENTION
[0001] The invention relates to the field of devices for anchoring and securement of medical lines and tubing.
BACKGROUND
[0002] Medical treatment of a subject (human or other mammal) often includes insertion of medical lines and tubing into the subject's body, for introduction or withdrawal of fluids, or for the delivery of medication and/or nutrition. Similarly, many medical monitoring and similar devices, such as ECG monitors, require the attachment of electrodes or sensors to the subject’s body, which are then connected through electrical leads extending from the electrode or sensor to an ambulatory or bedside monitoring.
[0003] In some cases, the medical lines and/or leads need to be secured to the subject’s body, to prevent entanglement and/or accidental disconnection of the lines/leads, e.g., due to subject movement, transfer, and/or position changes. The possible consequences of tubing or leads disconnection can be severe, and include bleeding, discharge of bodily fluids or medication, and/or loss of monitoring signal.
[0004] Most commonly, the lines/leads are secured simply by applying adhesive tape over the component and adhering the tape to the subject's skin. However, adhesive tapes typically do not provide a high level of securement, and their binding force tends to degrade over time, or to completely fail as the subject perspires or liquids spill on the site. In addition, adhesive tape can cause discomfort, skin irritation, or even local skin damage to the subject, and is often painful to remove. [0005] The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures.
SUMMARY
[0006] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.
[0007] There is provided, in an embodiment, a device comprising an elongate flexible band having a top surface and a bottom surface, the band comprising: (i) a proximal opening at a proximal end of the band, (ii) a first locking pin disposed distally of the proximal opening, (iii) a channel portion disposed distally of the first locking pin, the channel portion comprising at least one channel configured to releasably receive at least one medical line therein, (iv) a second locking pin disposed distally of the channel portion, and (v) a tail section extending distally from the second locking pin and comprising a series of spacedapart through-holes arranged lengthwise thereon, wherein the through-holes are each dimensioned to engage one of the first and second locking pins.
[0008] In some embodiments, the band is dimensioned for closing around a body part of a subject, by bringing the tail end around the body part towards said proximal end and advancing a specified portion of the tail section in a tightening direction through the proximal opening, to achieve a desired degree of tightening of the band around aid body part.
[0009] In some embodiments, the tail section comprises at least one side edge comprising a series of grip elements selected from the group consisting of: scalloping, prongs, barbs, grooves, channels, bumps, teeth, notches, serrations, surface roughening, and high-friction areas.
[0010] In some embodiments, the specified portion of the tail section is advanced through the proximal opening, the series of grip elements are configured to engage with an inside perimeter edge of the proximal opening, so as to resist a retraction of the specified portion of the tail section through the proximal opening in a loosening direction.
[0011] In some embodiments, upon advancing the specified portion of the tail section through the proximal opening, the first locking pin is configured to engage a nearest first one of the through-holes in the tail section.
[0012] In some embodiments, the first locking pin comprises a tooth-like projection oriented in the proximal direction.
[0013] In some embodiments, upon engaging the first one of the through-holes, the toothlike projection oriented in the proximal direction is configured to resist any tensional force applied to the specified portion of the tail section in the tightening direction, so as to maintain the desired degree of tightening of the band around the body part.
[0014] In some embodiments, the second locking pin comprises a tooth-like projection oriented in the distal direction.
[0015] In some embodiments, upon the engaging by the first locking pin of the first one of the through-holes, the specified portion of the tail section is configured to extend over the channel portion, such that the second locking pin engages a second one of the through- holes, wherein the tooth-like projection oriented in the distal direction is configured to resist any tensional force applied to the specified portion of the tail section in the loosening direction.
[0016] In some embodiments, each of the first and second locking pins comprises a first tooth-like projection oriented in the proximal direction, and a second tooth-like projection oriented in the distal direction.
[0017] In some embodiments, each of the channels defines a through -passageway that substantially transverses and extends across a width dimension of the channel portion.
[0018] In some embodiments, the medical line is selected from the group consisting of: tubing, hoses, cannulae, catheters, conduits, power cables, data cables, electrical leads, and electrical wires.
[0019] In some embodiments, each of the channels is configured to engage the at least one medical line about at least a part of its circumferential surface. [0020] In some embodiments, each of the channels has a cross-sectional shape selected from the group consisting of: circular, oval, square, rectangular, and polygonal.
[00 1] In some embodiments, each of the channels has a cross-section that is dimensioned such that a maximal circle inscribed within the cross-section has a diameter of between 2- 15mm.
[0022] In some embodiments, each of the channels is formed with an upper rim comprising a notch-like insertion slot comprising a pair of opposing lips of the upper rim, which define a gap having a specified width.
[0023] In some embodiments, the opposing lips may be resiliently deformed to widen the gap to permit an insertion of the at least one medical line through the insertion slot and into the through-passageway of the channel, wherein the opposing lips are configured to resiliently return to their original position upon the insertion.
[0024] In some embodiments, when in the original position, the insertion slot is configured to resist extrication of the at least one medical line from the channel.
[0025] In some embodiments, the gap is wider in at least one of its ends.
[0026] In some embodiments, each of the channels is numbered.
[0027] In some embodiments, the device further comprises a fastening loop located distally of the second locking pin and proximally of the tail section, wherein, upon the engaging by the second locking pin of the second one of the through-holes, the tail end is further configured to be threaded and advanced in the tightening direction through the fastening loop.
[0028] In some embodiments, the fastening loop comprises a concave area disposed underneath the fastening loop, wherein the concave area is configured to facilitate the threading and advancing of the tail end in the tightening direction.
[0029] In some embodiments, the concave area defines a through-aperture in the band, wherein the through aperture comprises a sloping tongue at a distal end thereof.
[0030] In some embodiments, the band is made of one or more of: rubber, thermoplastic elastomer (TPE), silicone rubber, another polymer, and metal. [0031] In some embodiments, at least the tail section is stretchable.
[0032] In some embodiments, at least a portion of the band comprises surface features selected from the group consisting of: ridges, divots, dimples, frictional elements, grooves, channels, bumps, surface roughening, and high-friction areas.
[0033] In some embodiments, the bottom surface of the band comprises surface features defining diagonal ridges.
[0034] There is also provided, in an embodiment, a method comprising: providing a device comprising an elongate flexible band having a top surface and a bottom surface, the band comprising: (i) a proximal opening at a proximal end of the band, (ii) a first locking pin disposed distally of the proximal opening, (iii) a channel portion disposed distally of the first locking pin, the channel portion comprising at least one channel configured to releasably receive at least one medical line therein, (iv) a second locking pin disposed distally of the channel portion, and (v) a tail section extending distally from the second locking pin and comprising a series of spaced-apart through-holes arranged lengthwise thereon, wherein the through-holes are each dimensioned to engage one of the first and second locking pins; closing the band around the body part of the subject, by bringing the tail end around the body part towards said proximal end, and advancing a specified portion of the tail section in a tightening direction through the proximal opening, to achieve a desired degree of tightening of the band around aid body part; engaging, by the first locking pin, a first one of the through-holes in the specified portion of the tail section; inserting at least one medical line in at least one channel in the channel portion; extending the specified portion of the tail section over the channel portion; and engaging, by the second locking pin, a second one of the through-holes.
[0035] In some embodiments, the tail section comprises at least one side edge comprising a series of grip elements selected from the group consisting of: scalloping, prongs, barbs, grooves, channels, bumps, teeth, notches, serrations, surface roughening, and high-friction areas.
[0036] In some embodiments, when the specified portion of the tail section is advanced through the proximal opening, the series of grip elements are configured to engage with an inside perimeter edge of the proximal opening, so as to resist a retraction of the specified portion of the tail section through the proximal opening in a loosening direction.
[0037] In some embodiments, the first locking pin comprises a tooth-like projection oriented in the proximal direction.
[0038] In some embodiments, upon engaging the first one of the through-holes, the toothlike projection oriented in the proximal direction is configured to resist any tensional force applied to the specified portion of the tail section in the tightening direction, so as to maintain the desired degree of tightening of the band around the body part.
[0039] In some embodiments, the second locking pin comprises a tooth-like projection oriented in the distal direction.
[0040] In some embodiments, upon engaging the second one of the through-holes by the second locking pin, the tooth- like projection oriented in the distal direction is configured to resist any tensional force applied to the specified portion of the tail section in the loosening direction.
[0041] In some embodiments, each of the first and second locking pins comprises a first tooth-like projection oriented in the proximal direction, and a second tooth-like projection oriented in the distal direction.
[0042] In some embodiments, each of the channels defines a through-passageway that substantially transverses and extends across a width dimension of the channel portion.
[0043] In some embodiments, the at least one medical line is selected from the group consisting of: tubing, hoses, cannulae, catheters, conduits, power cables, data cables, electrical leads, and electrical wires.
[0044] In some embodiments, each of the channels is configured to engage the at least one medical line about at least a part of its circumferential surface.
[0045] In some embodiments, each of the channels has a cross-sectional shape selected from the group consisting of: circular, oval, square, rectangular, and polygonal. [0046] In some embodiments, each of the channels has a cross-section that is dimensioned such that a maximal circle inscribed within the cross-section has a diameter of between 2- 15mm.
[0047] In some embodiments, each of the channels is formed with an upper rim comprising a notch-like insertion slot comprising a pair of opposing lips of the upper rim, which define a gap having a specified width.
[0048] In some embodiments, the opposing lips may be resiliently deformed to widen the gap to permit an insertion of the at least one medical line through the insertion slot and into the through-passageway of the channel, wherein the opposing lips are configured to resiliently return to their original position upon the insertion.
[0049] In some embodiments, when in the original position, the insertion slot is configured to resist extrication of the at least one medical line from the channel.
[0050] In some embodiments, the gap is wider in at least one of its ends.
[0051 ] In some embodiments, each of the at least one channels is numbered.
[0052] In some embodiments, the device further comprises a fastening loop located distally of the second locking pin and proximally of the tail section, wherein the method further comprises threading and advancing the tail end in the tightening direction through the fastening loop.
[0053] In some embodiments, the fastening loop comprises a concave area disposed underneath the fastening loop, wherein the concave area is configured to facilitate the threading and advancing of the tail end in the tightening direction.
[0054] In some embodiments, the concave area defines a through-aperture in the band, wherein the through aperture comprises a sloping tongue at a distal end thereof.
[0055] In some embodiments, the band is made of one or more of: rubber, thermoplastic elastomer (TPE), silicone rubber, another polymer, and metal.
[0056] In some embodiments, at least the tail section is stretchable. [0057] In some embodiments, at least a portion of the band comprises surface features selected from the group consisting of: ridges, divots, dimples, frictional elements, grooves, channels, bumps, surface roughening, and high-friction areas.
[0058] In some embodiments, the bottom surface of the band comprises surface features defining diagonal ridges.
[0059] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description.
BRIEF DESCRIPTION OF THE FIGURES
[0060] Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below.
[0061] Fig. 1 is a perspective view of a device of the present disclosure, according to some embodiments of the present disclosure;
[0062] Fig. 2 is a top view of a device of the present disclosure, according to some embodiments of the present disclosure;
[0063] Fig. 3 is a bottom view of a device of the present disclosure, according to some embodiments of the present disclosure;
[0064] Fig. 4 is a side view of a device of the present disclosure, according to some embodiments of the present disclosure;
[0065] Fig. 5A-5B are flowcharts of the functional steps in a method for application to the human body of a device for anchoring, securing, and/or stabilizing of medical lines to a desired location on a body of a subject, according to some embodiments of the present disclosure;
[0066] Fig. 6 illustrates the application of a device of the present disclosure to a body part of a subject, according to some embodiments of the present disclosure; [0067] Figs. 7A-7C illustrate the steps in the process for anchoring and securing one or more medical lines within respective medical line channels, according to some embodiments of the present disclosure;
[0068] Figs. 8A-8C are, respectively, enlarged perspective, top, and side views of a first locking zone, a channel zone, and a second locking zone of a device of the present disclosure, according to some embodiments of the present disclosure;
[0069] Fig. 9 is an enlarged perspective view of a second locking zone of a device of the present disclosure, according to some embodiments of the present disclosure;
[0070] Figs. 10A-10B show enlarged detail of locking pins of a device of the present disclosure, according to some embodiments of the present disclosure;
[0071] Figs. 11A-11B are additional perspectives views of a device of the present disclosure, according to some embodiments of the present disclosure; and
[0072] Fig. 12 shows a detail of a bottom surface of a device of the present disclosure, according to some embodiments of the present disclosure.
DETAILED DESCRIPTION
[0073] In accordance with some aspects of the present invention, disclosed are devices and methods configured for anchoring, securing, and/or stabilizing medical lines and/or leads to a desired location on a body of a subject, for use during administration of therapy and/or monitoring of physiological parameters in the subject.
[0074] As used herein, the term ‘medical line’ refers generally to any medical lines, tubing, hoses, cannulae, catheters, sheaths, and/or similar conduits used, e.g., in intravenous (IV) therapy; for purposes of fluid replacement, drainage, and/or withdrawal; and/or to administer medications, nutrients, volume expanders, blood-based products, and/or other fluids; and/or intraarterial (IA) line for blood pressure continuous measurement, blood withdrawal, and/or intraarterial therapy (catheterization, ECMO, etc.). The term ‘medical line’ as used herein further encompasses any power or data cables, leads, wires, and/or similar electrical lines used to transmit electrical power, electrical signals, data, and/or any similar transmission from a body site to a remote monitoring unit. [0075] The present disclosure will discuss extensively applications of the present device in the context of IV therapy involving an IV catheter. However, as will be apparent to those skilled in the art, the present disclosure is equally effective with respect to any other types of medical lines and/or signal leads, which require securement at a desired bodily site.
[0076] Because medical lines can span several feet in length, they are susceptible to getting pulled, snagged, or tangled, which may cause unwanted movement or displacement of the line. In addition, subject motion can cause the line to move or dislocate. If the tensional force applied to the line as a result of movement becomes excessive, the line could potentially disconnect from the catheter, or the catheter itself could be yanked out of place, causing discontinuance of the therapy, and potential blood, fluid, or medication spill and loss.
[0077] To prevent these situations, lines are typically secured or stabilized to the subject's body in a way which assumes any tensional force applied to the line at the securement location, and prevents unwanted movement or displacement forces to be transmitted further to the insertion site to the body. Stabilizing the line thus prevents the line from getting pulled, snagged, bent, twisted, or tangled; prevents the line from inadvertently causing tensional stress to the catheter and surrounding area of the catheter insertion site; and relieves the subject or healthcare professional from the burden of having to hold the line during administration of liquids.
[0078] Healthcare practitioners often secure the line to the subject's body using adhesive tape or dressing. The adhesive tape or dressing is applied on top of the line and directly to the subject's skin. Sometimes, multiple strips of adhesive tape or dressing are needed to stabilize the line. However, the use of adhesive tape or dressing presents several disadvantages. For example, moisture and perspiration can degrade the adhesive or cause it to fail. In addition, adhesive tape or dressing needs to be replaced from time to time, creating discomfort and inconvenience to the subject. Adhesive tape or dressing is also not re-usable, creating the need to use new adhesive tape or dressing every time a line needs to be inserted or replaced, which results in higher consumption. Finally, adhesive tape or dressing can cause discomfort, annoyance, or even local skin damage to the subject, especially upon removal. [0079] Accordingly, in some embodiments, the present disclosure provides for a medical line anchoring device which is configured to secure one or more medical lines at a desired site on a subject’s body, in a way which ensures that the one or more lines will not be displaced, pulled out, or otherwise disconnected from the insertion site. The present device is simple in design, easy to produce, its application to the subject is straightforward, and it can be re-used multiple times, thus reducing potential waste and promoting sustainability.
[0080] The present device is configured to be fastened or closed around a circumference of a body part of a subject, and can be applied with an adjustable degree of fastening or tightness, to prevent any long-term discomfort to the subject. Once fastened, one or more medical lines of various types and sizes may be inserted and securely anchored, in a way which is independent of, and does not affect or disturb, the fastening of the device around the body part. Thus, any addition, removal, and/or replacement of one or more medical lines within the fastened device does not involve any opening, loosening, tightening, and/or retightening of the fastened device around the body part. As a result, the device maintains a steady degree of fastening around the body part of the subject throughout the duration of the therapy (which may involve multiple occasions of adding, removing, and/or replacing individual medical lines), and thus avoids even momentary discomfort or annoyance to the subject.
[0081 ] A potential advantage of the present device is, therefore, in that it provides for fast, easy and secure addition, removal and/or replacement and of multiple individual medical lines to the present device, while it is fastened around a body part, without the need to loosen or remove the device, without disturbing any other of anchored lines, and without causing any pain or discomfort to the subject. In addition, the present device provides for visual organization of multiple medical lines being used at once with respect to a subject, such that the multiple lines are presented visually in a well-ordered and easy-to-distinguish manner, thus reducing the potential for errors in the administration of therapy by medical practitioners.
[0082] Reference is made to Fig. 1 , which is a perspective view of an exemplary device for anchoring, securing, and/or stabilizing of medical lines to a desired location on a body of a subject, according to some embodiments of the present disclosure. Figs. 2, 3 and 4 are, respectively, a top view, a bottom view, and a side view of band 100 shown in perspective view in Fig. 1.
[0083] In some embodiments, the exemplary device of the present disclosure comprises a band 100 comprising a flexible, elongate strip of material, e.g., a strap, a band, a sleeve, or the like, configured to surroundingly -engage (i.e., close or fasten around a circumference of) a body part of a subject. In some embodiments, band 100 may be dimensioned to close around a circumference of a body part or a bodily region of a subject, e.g., an arm, a forearm, a wrist, a leg, a thigh, an ankle, a limb, a neck, a head, a torso, etc.
[0084] In some embodiments, band 100 has a length of between, e.g., 90-660mm. In some embodiments, band 100 has a width of between, e.g., 10-25mm.
[0085] In some embodiments, band 100 generally defines a flat elongate strap or band having a top surface 102 and a bottom surface 104, wherein bottom surface 104 is a skincontacting surface of band 100. When band 100 is closed or fastened around a body part, top surface 102 becomes an outer-facing surface of band 100, and bottom surface 104 becomes an inner-facing surface of band 100.
[0086] In some embodiments, band 100 comprises one or more of the following sections, e.g.:
A setting zone A extending from tail end 106 proximally, in the direction of proximal end 108, and comprising an array or a series of through holes 110, spacedapart lengthwise at predetermined intervals along at least a portion of a length of setting zone A. In some embodiments, at least a portion of setting zone A comprises at least one side edge featuring a scalloped, toothed, notched, jagged, serrated and/or otherwise a saw-like design, e.g., one or more of side edges 112; a first locking zone LI extending from proximal end 108 distally, in the direction of tail end 106, and comprising, e.g., a proximal opening 124 and a first locking pin 120; a second locking zone L2 extending from a proximal end of setting zone A proximally, in the direction of proximal end 108, and comprising, e.g., a second locking pin 122, a fastening loop 126, and a concave area 128 underneath fastening loop 126; and a channel zone B extending between the first and second locking zones LI and L2, and comprising one or more channels 130, each configured to receive and anchor a medical line therein. In some embodiments, channel zone B comprises, e.g., at least one channel, or at least 2, 3, 4, 5, or 10 channels.
[0087] Figs. 5A-5B are flowcharts of the functional steps in a method 500 for application to the human body of a device (such as band 100 shown in Figs. 1-4) for anchoring, securing, and/or stabilizing of medical lines to a desired location on a body of a subject, according to some embodiments of the present disclosure.
[0088] Method 500 begins in step 502, wherein, as illustrated in Fig. 6, band 100 may be positioned in proximity to a desired body site, e.g., an arm, a forearm, a wrist, a leg, a thigh, an ankle, a limb, a neck, a head, a torso, to be closed and fastened around it. Thus, in some embodiments and 100 may be configured for being wound around a body part 140, e.g., by bringing tail end 106 around body part 140 (e.g., a wrist in this case), so as to close around and surroundingly engage body part 140.
[0089] In some embodiments, tail end 106 may then be negotiated or threaded through proximal opening 124 located at proximal end 108, and advanced therethrough. In some embodiments, tail end 106, once threaded through opening 124, may be advanced or pulled through opening 124, such that an overlapping portion of band 100 extends from proximal end 108. In some embodiments, an extent to which tail end 106 is advanced and extends through opening 124 determines a degree of tightness of band 100 around body part 140.
[0090] For some applications, tail end 106 may also be pulled back against an outer lip of opening 124, so as to gain a mechanical advantage in establishing a degree of fastening or tightness of band 100 around body part 140, similar to the way a belt might be tightened. For example, this method of tightening using the mechanical advantage may be used to produce momentary greater tightness, e.g., to facilitate insertion of a needle to a peripheral vein, which tightness may then be released and set a desired level.
[0091] In some embodiments, side edges 112 are configured to cooperate with an inside perimeter edge of opening 124, to provide for mechanical and/or frictional engagement between side edges 112 and the internal perimeter edge of opening 124, which works to resist the retraction back of the portion of setting zone A advanced through opening 124, other than through the intentional application of force calculated to retract setting zone A from opening 124. As noted above, side edges 112 may comprise a series of grip and/or frictional elements along at least a portion of a length of setting zone A, such as scalloping, prongs, barbs, grooves, channels, bumps, teeth, notches, serration, surface roughening, high-friction pads, and/or any other suitable grip and/or frictional element.
[0092] Thus, once band 100 is optimally fitted to body part 140, side edges 112 cooperate with opening 124 to retain the portion of setting zone A advanced through opening 124 and to maintain the desired degree of fastening or tightness of band 100 around the body part.
[0093] In some embodiments, in step 504-510 in Fig. 5A, an overlapping portion of a length of setting zone A which has been brought around the body part, advanced through opening 124, and extends beyond opening 124 and towards zones B and L2, may then be used to anchor and secure one or more medical lines within respective channels 130 in channel zone B, as shall be detailed further below.
[0094] Reference is made to Figs. 7A-7C, which illustrate the functional steps in the process for anchoring and securing one or more medical lines within respective channels 130 in channel zone B.
[0095] First, in step 504, as can be seen in Fig. 7A, an overlapping portion 106a of setting zone A, which extends from opening 124 in a tightening direction marked by arrow X, may be secured to first locking pin 120 within first locking zone LI, e.g., by removably engaging an optimum hole 110 (for example, the nearest one of holes 110 when band 100 is optimally fitted to body part 140) with locking pin 120.
[0096] In some embodiments, engaging the selected hole 110 with first locking pin 120 may be achieved by pressing the area surrounding the selected hole 110 directly onto locking pin 120, thereby causing the selected hole 110 to elastically expand and receive locking pin 120 therein. Additionally or alternatively, overlapping portion 106a may be stretched to enlarge and/or elongate the selected hole 110, so as to slip the selected hole 110 over locking pin 120. [0097] In some embodiments, as can be seen in Figs. 7A and 7B, locking pin 120 comprises a tooth-like projection 120a oriented in the proximal direction. By expanding, enlarging, and/or elongating the selected hole 110, the selected hole 110 may be slipped over locking pin 120 past the area comprising projection 120a. Once reaching the area below projection 120a, the selected hole 110 may return to its original dimensions, and thus be prevented from being dislodged unintentionally from locking pin 120.
[0098] As noted above, at this stage, band 100 is fastened and closed around the body part to a desired degree of fastening or tightness, and side edges 112 and opening 124 cooperate to retain the portion of setting zone A advanced through opening 124 and resist its retraction back through opening 124.
[0099] By engaging a selected hole 110 with first locking pin 120, it is ensured that the established level of fastening or tightness is maintained throughout the rest of the application procedure of band 100, regardless of any tensional force or other manipulation applied to the overlapping portion 106a in the tightening direction, e.g., in the direction of arrow X. In other words, any additional force applied to overlapping portion 106a in the direction of arrow X is resisted by locking pin 120, and would not cause band 100 to further tighten around the body part. In addition, tooth-like projection 120a prevents selected hole 110 from disengaging from locking pin 120 as a result of any additional force being applied to overlapping portion 106a in the direction of arrow X.
[00100] Thus, the level of comfort of the subject is maintained, and no additional unwanted tightening of band 100 occurs as a result of the actions performed in steps 504-508, as detailed below.
[00101] As can be seen particularly in Fig. 7 A, the design of first locking pin 120 and projection 120a tends to prevent the selected hole 110 from being dislodged due to any tensional force applied to overlapping portion 106a or to tail end 106 in the tightening direction, e.g., in the direction of arrow X, which otherwise would work to further tighten band 100 around body part 140.
[00102] Accordingly, as can be seen in Figs. 7B-7C, as overlapping portion 106a is being manipulated and used to anchor and secure one or more medical lines 142 within respective channels 130, any tensional force resulting from the manipulation is assumed by the first locking pin 120, and it is thus ensured that the degree of tightness of band 100 around the body part 140 remains unchanged throughout this process.
[00103] Returning back to Fig. 5 A, in step 506, as can further be seen in Fig. 7B, one or more medical lines 142 may be inserted into respective channels 130. Each of channels 130 is dimensioned and configured to releasably receive one medical line 142 therein.
[00104] Reference is made to Figs. 8A-8C, which are, respectively, enlarged perspective, top, and side views of portions LI, B, and L2 of band 100.
[00105] As can be seen in Figs. 8A-8C, each of channels 130 defines a through passageway that substantially transverses and extends across a width dimension of channel zone B of band 100. In some embodiments, each of channels 130 is dimensioned and configured to releasably receive a respective one of a plurality of medical lines (142 in Figs. 7B-7C and 8C), and to engage the received medical line 142 about at least a part of its circumferential surface along the length of channel 130.
[00106] In some embodiments, a cross-sectional shape of each channel 130 may be, e.g., circular, oval, polygonal, and/or any other suitable cross-sectional shape configured to engage a section of a medical line 142 received within channel 130 about at least a part of its circumference along the length of channel 130.
[00107] In some embodiments, a cross-section dimension of each channel 130 may be configured to receive medical lines of varying sizes and diameters. In some embodiments, each channel 130 may be dimensioned such that a maximal circle inscribed within its crosssection has a diameter of between, e.g., 2-15mm. In some embodiments, each channel 130 is dimensioned to receive and securely retain therein a medical line of a specified size or a range of sizes, and to apply sufficient frictional force about at least a portion of the circumference of the received line, so as to resist the unintentional release or axial movement of the line while received within channel 130. In some embodiments, at least one of channels 130 within band 100 may be dimensioned and configured to receive two or more medical lines therein.
[00108] In some embodiments, when a channel zone B comprises more than one channel 130, all individual channels 130 may have identical cross-sectional shape and dimension. However, in other embodiments, two or more channels 130 within the same channel zone B may have varying cross-sectional shapes and dimensions.
[00109] In some embodiments, each of channels 130 may be formed with an upper rim formed with a notch-like elastic insertion slot 130a. In some embodiments, insertion slots 130a are defined by opposing lips of a respective channel 130 defining a narrow gap therebetween. In some embodiments, the insertion slots 130a are formed of a resiliently pliable material, wherein the opposing lips of the insertion slots 130a may be resiliently deformed to widen the gap and permit the insertion of a medical line 142 therethrough and into the through-passageway of channel 130, and, once the medical line has passed through the respective insertion slot 130a, to resiliently return to their original position and close the gap above the medical line received within channel 130, and thus work to retain the medical line within the respective channel 130 and to prevent its unintentional extrication. A medical line may be extricated from a channel 130 by applying an extricating force which tends to pull medical line 142 of its respective channel 130, again, by momentarily widening the respective insertion slot 130a by resiliently deforming the opposing lips of channel 130.
[00110] As can be seen for example in Fig. 8B, in some embodiments, insertion slots 130a may define a gap which is not of a consistent width along its length, e.g., a gap which is wider at one or both ends, and narrows towards the middle. Such configuration of insertion slots 130a may facilitate the insertion of a medical line 142 (e.g., as shown in Fig 8C), wherein the line is initially being forced against one of the wider areas of the gap, to facilitate the opening of the insertion slot 130a, without requiring the need to manually separate the opposing lips of channel 130, e.g., using fingers or a suitable tool. Once sufficiently open, the medical line 142 (shown in Fig 8C) may be slipped in through insertion slot 130a and into channel 130a, wherein insertion slot may resiliently return to their original shape.
[00111] In some embodiments, as can be seen in Figs. 8A-8B, channels 130 may be numbered 130b, such as to facilitate the organizing and visual presentation of the medical lines 142 (shown in Fig 8C) in a well-ordered and easy-to-distinguish manner, thus reducing the potential for errors in the administration of therapy by medical practitioners. [00112] With reference back to Figs. 5 and 7B-7C, in step 508, overlapping portion 106a may be secured over channel zone B, by removably engaging second locking pin 122. For example, once medical lines 142 (shown in Fig 8C) are inserted within respective channels 130, overlapping portion 106a may be pulled and stretched over channel zone B, and then secured by, e.g., removably engaging a nearest or selected one of holes 110 with locking pin 122.
[00113] In some embodiments, as can be seen in Figs. 7A and 7B, locking pin 122 comprises a tooth-like projection 122a oriented in the distal direction. By expanding, enlarging, and/or elongating the selected hole 110, the selected hole 110 may be slipped over locking pin 122 past the area comprising projection 122a. Once reaching the area below projection 122a, the selected hole 110 may return to its original dimensions, and thus be prevented from being dislodged unintentionally from locking pin 122.
[00114] In some embodiments, the design of second locking pin 122 and projection 122a, once removably engaged with a hole 110, tends to counter any tensional force applied to overlapping portion 106a in the loosening direction, e.g., the opposite direction to the direction of arrow X. thus, the section of overlapping portion 106a covering channel zone B, e.g., between first and second locking pins 120 and 122, may be maintained at a slightly tensioned state by projections 120a and 122a, to as to securely anchor medical lines 142 in respective channels 130.
[001 15] Thus, first and second locking pins 120, 122 and projections 120a, 122a, respectively, may cooperate to retain a degree of tensioning in the section of overlapping portion 106a extending between first and second locking pins 120, 122. In some embodiments, the operation of removably engaging a respective hole 110 of overlapping portion 106 with second locking pin 122 may involve slightly stretching overlapping portion 106 (which is already removably engaged with first locking pin 120, providing a counter force to the stretching action), e.g., by pulling on tail end 106, in the direction of arrow X. Thus, as noted above, the stretching action does not affect the tightening level of band 100 around body part 140, because the stretching force is countered by the design of first locking pin 120. [00116] In some embodiments, in step 510, with continued reference to Fig. 7C and with reference to Fig. 9, tail end 106 may be threaded and advanced through fastening loop 126, to secure any dangling remainder of overlapping portion 106a, to prevent the potential risk of unintentional disengagement of overlapping portion 106 from second locking pin 122. In some embodiments, a dip, a concavity, or a through-aperture area 128 may be provided in locking zone L2 of band 100, generally underneath fastening loop 126. Concave area 128 may comprise a sloping tongue 128a at a distal end thereof, which may be disposed at a bias relative to a transverse axis defined by band 100. Tongue 128a may be configured to facilitate the threading and advancing of tail end 106 through fastening loop 126, so as to prevent tail 106 from being trapped or wedged underneath fastening loop 126 as it is being advanced therethrough, and urge tail end 106 upwardly and out from under fastening loop 126.
[00117] With reference now to Fig. 5B, in some embodiments, in steps 512-520, one or more of medical lines 142 may be added, removed, and/or replaced within channel zone B.
[00118] Accordingly, in some embodiments, in step 512, overlapping portion 106a may be retracted back through fastening loop 126.
[00119] In step 514, the respective hole 110 is disengaged from second locking pin 122.
[00120] In step 516, overlapping portion 106a may be lifted or peeled back (to a position similar to that shown in Fig. 7A) to expose channel zone B and channels 130. One or more medical lines 142 (shown in Figs. 7B-7C and 8C) may be added, removed, and/or replaced, as detailed with reference to step 504. Then steps 506-508 may be repeated to secure channel zone B again.
[00121] In step 518, similarly to step 508, overlapping portion 106a may be re-secured over channel zone B, by removably engaging second locking pin 122.
[00122] In step 520, similarly to step 510, tail end 106 may be re-threaded and advanced through fastening loop 126, to secure any dangling remainder of overlapping portion 106a.
[00123] Figs. 10A-10B show locking pins 120, 122 in enlarged detail. In Fig. 10A, each locking pin 120, 122 has a single tooth-like projection 120a, 122a, respectively. Projection 120a is oriented in the proximal direction, while projection 122a is oriented in the distal direction. In Fig. 10B, each locking pin 120, 122 has two tooth-like projections 120a- 120b, and 122a-122b, respectively. Projections 120a and 122b are oriented in the proximal direction, while projections 120b and 122a are oriented in the distal direction.
[00124] Figs. 11A-11B show additional perspective views of an exemplary device for anchoring, securing, and/or stabilizing of medical lines to a desired location on a body of a subject, according to some embodiments of the present disclosure.
[00125] In some embodiments, band 100 may be made of any suitable material, comprising for example, rubber, thermoplastic elastomer (TPE), silicone rubber, plastic, any other polymer known in the art, or metal, and is preferably constructed to provide nonslip characteristics on its surface to aid in gripping. One or more portions of band 100 may have surface features, e.g. ridges, divots, dimples, frictional elements, grooves, channels, bumps, surface roughening, and/or high-friction areas, and the like, to aid in gripping. With reference to Fig. 12, in some embodiments, a bottom surface 104 may have surface features such as ridges 146, which may run diagonally relative to a transverse axis defined by band 100, to aid in expelling moisture or providing ventilation, in areas prone to accumulation of moisture, e.g., due to perspiration by the subject.
[00126] Band 100 may be made of a single piece of polymeric material, e.g., by molding or additive manufacturing methods (e.g., 3D printing). Alternatively, band 100 may comprise several polymeric materials having different mechanical properties adapted to the constraints that the different parts of the device are subjected to. For example, it is possible to use a more rigid polymer for the first and second locking pins 120, 122, and a more pliable polymer to construct channels 130.
[00127] Accordingly, in some embodiments, band 100 may be integrally formed, e.g., as a unitary element made of a single material, e.g., using an injection process. In other embodiments, band 100 may comprise two or more different materials in different parts thereof, or different varieties of the same material in different parts thereof, e.g., having varying mechanical properties, such as pliability, rigidity, elasticity, stretchability, etc. for example, band 100 may be produced using an over-molding process enabling materials of different mechanical properties to be over-molded and/or assembled in order to mold various parts of band 100 (e.g., proximal opening 124, first and second locking pins 120 and 122, channel zone B, channels 130, fastening loop 126, and/or concave area 128 and tongue 128a) using materials having different mechanical properties. In some embodiments, certain parts, e.g., channels 130 and/or other parts may be separately formed, e.g., a inserts to be attached to band 100. In some embodiments, channels 130 may be integrally formed with band 100, however, channels 130 may be configured to receive replaceable inserts designed to receive and secure medical lines of varying shapes, sizes, and diameters.
[00128] In some embodiments, channel zone B may be an interchangeable channel zone, wherein band 100 may be configured to allow attachment and/or replacement of a separately-formed channel zone B therein. Thus, a channel zone B may be selected from a variety of different channel zones, each comprising, e.g., a different number of channels 130, which may be of different cross-sectional shapes and/or dimensions. The selected channel zone B may then be attached to the band 100 at the designated space allocated within band 100, to serve as the channel zone B.
[00129] In some embodiments, band 100 may be produced in a variety of colors, wherein a specified color (e.g., red, blue, or yellow) may be associated with a particular medical center, type of treatment, or subject pathology.
[00130] In some embodiments, band 100 may be configured for linking with one or more other devices 100, e.g., to produce a longer version of band 100, e.g., which can fit body parts of a larger diameter, e.g., neck, head, torso, etc.
[00131] In some embodiments, band 100 of the present disclosure may comprise one or more integrated sensors which may comprise characteristics of any of a variety of different types of sensors, signals from which may be analyzed to ascertain a health status of a subject. Such sensors may, for example, comprise physiological sensors that operate to monitor physiological characteristics of a subject, e.g.: heart monitoring sensors, heart -rate monitoring sensors, electrocardiogram (ECG) sensors, body temperature sensors, breath- rate/respiration sensors (e.g., pressure-based and/or acoustic-based), skin conductivity sensors, oxygen saturation sensors, blood perfusion sensors, skin humidity sensors, electroencephalograph (EEG) sensors, and/or muscle activity sensors. In some embodiments, such sensors may also comprise non -physiological sensors that operate to monitor characteristics other than physiological characteristics of the subject. Such non- physiological sensors may, for example, comprise environmental sensors that operate to monitor aspects of the environment in which a subject is performing a task. For example and without limitation, such environmental sensors may comprise: air temperature sensors, air speed sensors, humidity sensors, air oxygen level sensors, barometric pressure sensors, altitude/elevation sensors, precipitation sensors, light sensors, movement sensors, multi - axes accelerometers, location sensors/systems (e.g., global positioning system (GPS) sensors, ranging and direction sensors, terrestrial triangulation sensors/systems (e.g., cellular communication system based, premises based, campus based, etc.)), time sensors (e.g., time change and/or absolute time), orientation sensors, etc. Such non -physiological sensors may also, for example, comprise situational sensors that operate to monitor characteristics of a physical situation (e.g., a task or activity) in which the subject is engaged. Such situation (or activity) sensors may, for example and without limitation, comprise: weight sensors, impact sensors, force sensors, pressure sensors, accelerometers, inclinometers, motion sensors, speed and/or velocity sensors, etc.
[00132] In some embodiments, band 100 may comprise an identification module, e.g., a radio-frequency ID (RFID) or a near-field communication (NFC) tags, which may be used to identify a subject with respect to whom band 100 in being used.
[00133] In some embodiments, band 100 may comprise a communications module via which band 100 may communicate with other systems and/or other devices utilizing wired and/or wireless communication, e.g., any short- or long-range wireless communications protocol, such as wi-fi, Bluetooth, ZigBee, cellular communications, any other radiofrequency protocol, etc.
[001 4] The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein. [00135] In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated. In addition, where there are inconsistencies between this application and any document incorporated by reference, it is hereby intended that the present application controls.

Claims

CLAIMS What is claimed is:
1. A device comprising: an elongate flexible band having a top surface and a bottom surface, said band comprising:
(i) a proximal opening at a proximal end of said band,
(ii) a first locking pin disposed distally of said proximal opening,
(iii) a channel portion disposed distally of said first locking pin, said channel portion comprising at least one channel configured to releasably receive at least one medical line therein,
(iv) a second locking pin disposed distally of said channel portion, and
(v) a tail section extending distally from said second locking pin and comprising a series of spaced-apart through-holes arranged lengthwise thereon, wherein said through-holes are each dimensioned to engage one of said first and second locking pins.
2. The device of claim 1, wherein said band is dimensioned for closing around a body part of a subject, by bringing said tail end around said body part towards said proximal end, and advancing a specified portion of said tail section in a tightening direction through said proximal opening, to achieve a desired degree of tightening of said band around aid body part.
3. The device of any one of claims 1 or 2, wherein said tail section comprises at least one side edge comprising a series of grip elements selected from the group consisting of: scalloping, prongs, barbs, grooves, channels, bumps, teeth, notches, serrations, surface roughening, and high-friction areas.
4. The device of claim 3, wherein, when said specified portion of said tail section is advanced through said proximal opening, said series of grip elements are configured to engage with an inside perimeter edge of said proximal opening, so as to resist a retraction of said specified portion of said tail section through said proximal opening in a loosening direction.
5. The device of any one of claims 2-4, wherein, upon advancing said specified portion of said tail section through said proximal opening, said first locking pin is configured to engage a nearest first one of said through-holes in said tail section.
6. The device of any one of claims 1-5, wherein said first locking pin comprises a tooth- like projection oriented in the proximal direction.
7. The device of claim 6, wherein, upon engaging said first one of said through-holes, said tooth-like projection oriented in the proximal direction is configured to resist any tensional force applied to said specified portion of said tail section in said tightening direction, so as to maintain said desired degree of tightening of said band around said body part.
8. The device of any one of claims 1-7, wherein said second locking pin comprises a tooth-like projection oriented in the distal direction.
9. The device of claim 8, wherein, upon said engaging by said first locking pin of said first one of said through-holes, said specified portion of said tail section is configured to extend over said channel portion, such that said second locking pin engages a second one of said through-holes, and wherein said tooth-like projection oriented in the distal direction is configured to resist any tensional force applied to said specified portion of said tail section in said loosening direction.
10. The device of any one of claims 1-9, wherein each of said first and second locking pins comprises a first tooth-like projection oriented in the proximal direction, and a second tooth-like projection oriented in the distal direction.
11. The device of any one of claims 1-10, wherein each of said channels defines a through-passageway that substantially transverses and extends across a width dimension of said channel portion.
12. The device of any one of claims 1-11, wherein said medical line is selected from the group consisting of: tubing, hoses, cannulae, catheters, conduits, power cables, data cables, electrical leads, and electrical wires.
13. The device of any one of claims 1-12, wherein each of said channels is configured to engage said at least one medical line about at least a part of its circumferential surface.
14. The device of any one of claims 1-13, wherein each of said channels has a cross- sectional shape selected from the group consisting of: circular, oval, square, rectangular, and polygonal.
15. The device of any one of claims 1-14, wherein each of said channels has a crosssection that is dimensioned such that a maximal circle inscribed within said cross-section has a diameter of between 2- 15mm.
16. The device of any one of claims 1-15, wherein each of said channels is formed with an upper rim comprising a notch-like insertion slot comprising a pair of opposing lips of said upper rim, which define a gap having a specified width.
17. The device of claim 16, wherein said opposing lips may be resiliently deformed to widen said gap to permit an insertion of said at least one medical line through said insertion slot and into said through-passageway of said channel, and wherein said opposing lips are configured to resiliently return to their original position upon said insertion.
18. The device of claim 17, wherein, when in said original position, said insertion slot is configured to resist extrication of said at least one medical line from said channel.
19. The device of any one of claims 15-18, wherein said gap is wider in at least one of its ends.
20. The device of any one of claims 1-19, wherein each of said channels is numbered.
21. The device of any one of claims 1 -20, further comprising a fastening loop located distally of said second locking pin and proximally of said tail section, and wherein, upon said engaging by said second locking pin of said second one of said through-holes, said tail end is further configured to be threaded and advanced in said tightening direction through said fastening loop.
22. The device of claim 21, wherein said fastening loop comprises a concave area disposed underneath said fastening loop, and wherein said concave area is configured to facilitate said threading and advancing of said tail end in said tightening direction.
23. The device of claim 22, wherein said concave area defines a through-aperture in said band, and wherein said through aperture comprises a sloping tongue at a distal end thereof.
24. The device of any one of claims 1-23, wherein said band is made of one or more of: rubber, thermoplastic elastomer (TPE), silicone rubber, another polymer, and metal.
25. The device of any one of claims 1-24, wherein at least said tail section is stretchable.
26. The device of any one of claims 1-25, wherein at least a portion of said band comprises surface features selected from the group consisting of: ridges, divots, dimples, frictional elements, grooves, channels, bumps, surface roughening, and high-friction areas.
27. The device of any one of claims 1-26, wherein said bottom surface of said band comprises surface features defining diagonal ridges.
28. A method comprising: providing a device comprising: an elongate flexible band having a top surface and a bottom surface, said band comprising:
(i) a proximal opening at a proximal end of said band,
(ii) a first locking pin disposed distally of said proximal opening,
(iii) a channel portion disposed distally of said first locking pin, said channel portion comprising at least one channel configured to releasably receive at least one medical line therein,
(iv) a second locking pin disposed distally of said channel portion, and
(v) a tail section extending distally from said second locking pin and comprising a series of spaced-apart through-holes arranged lengthwise thereon, wherein said through-holes are each dimensioned to engage one of said first and second locking pins; closing said band around said body part of said subject, by bringing said tail end around said body part towards said proximal end, and advancing a specified portion of said tail section in a tightening direction through said proximal opening, to achieve a desired degree of tightening of said band around aid body part; engaging, by said first locking pin, a first one of said through-holes in said specified portion of said tail section; inserting at least one medical line in at least one channel in said channel portion; extending said specified portion of said tail section over said channel portion; and engaging, by said second locking pin, a second one of said through-holes.
29. The method of claim 28, wherein said tail section comprises at least one side edge comprising a series of grip elements selected from the group consisting of: scalloping, prongs, barbs, grooves, channels, bumps, teeth, notches, serrations, surface roughening, and high-friction areas.
30. The method of claim 29, wherein, when said specified portion of said tail section is advanced through said proximal opening, said series of grip elements are configured to engage with an inside perimeter edge of said proximal opening, so as to resist a retraction of said specified portion of said tail section through said proximal opening in a loosening direction.
31. The method of any one of claims 28-30, wherein said first locking pin comprises a tooth- like projection oriented in the proximal direction.
32. The method of claim 31, wherein, upon engaging said first one of said through- holes, said tooth-like projection oriented in the proximal direction is configured to resist any tensional force applied to said specified portion of said tail section in said tightening direction, so as to maintain said desired degree of tightening of said band around said body part.
33. The method of any one of claims 28-32, wherein said second locking pin comprises a tooth-like projection oriented in the distal direction.
34. The method of claim 33, wherein, upon engaging said second one of said through- holes by said second locking pin, said tooth-like projection oriented in the distal direction is configured to resist any tensional force applied to said specified portion of said tail section in said loosening direction.
35. The method of any one of claims 28-34, wherein each of said first and second locking pins comprises a first tooth-like projection oriented in the proximal direction, and a second tooth-like projection oriented in the distal direction.
36. The method of any one of claims 28-35, wherein each of said channels defines a through-passageway that substantially transverses and extends across a width dimension of said channel portion.
37. The method of any one of claims 28-36, wherein said at least one medical line is selected from the group consisting of: tubing, hoses, cannulae, catheters, conduits, power cables, data cables, electrical leads, and electrical wires.
38. The method of any one of claims 28-37, wherein each of said channels is configured to engage said at least one medical line about at least a part of its circumferential surface.
39. The method of any one of claims 28-38, wherein each of said channels has a cross- sectional shape selected from the group consisting of: circular, oval, square, rectangular, and polygonal.
40. The method of any one of claims 28-39, wherein each of said channels has a crosssection that is dimensioned such that a maximal circle inscribed within said cross -section has a diameter of between 2- 15mm.
41. The method of any one of claims 28-40, wherein each of said channels is formed with an upper rim comprising a notch-like insertion slot comprising a pair of opposing lips of said upper rim, which define a gap having a specified width.
42. The method of claim 41, wherein said opposing lips may be resiliently deformed to widen said gap to permit an insertion of said at least one medical line through said insertion slot and into said through-passageway of said channel, and wherein said opposing lips are configured to resiliently return to their original position upon said insertion.
43. The method of claim 42, wherein, when in said original position, said insertion slot is configured to resist extrication of said at least one medical line from said channel.
44. The method of any one of claims 41-43, wherein said gap is wider in at least one of its ends.
45. The method of any one of claims 28-44, wherein each of said at least one channels is numbered.
46. The method of any one of claims 28-45, wherein said device further comprises a fastening loop located distally of said second locking pin and proximally of said tail section, and wherein said method further comprises threading and advancing said tail end in said tightening direction through said fastening loop.
47. The method of claim 46, wherein said fastening loop comprises a concave area disposed underneath said fastening loop, and wherein said concave area is configured to facilitate said threading and advancing of said tail end in said tightening direction.
48. The method of claim 47, wherein said concave area defines a through-aperture in said band, and wherein said through aperture comprises a sloping tongue at a distal end thereof.
49. The method of any one of claims 28-48, wherein said band is made of one or more of: rubber, thermoplastic elastomer (TPE), silicone rubber, another polymer, and metal.
50. The method of any one of claims 28-49, wherein at least said tail section is stretchable.
51. The method of any one of claims 28-50, wherein at least a portion of said band comprises surface features selected from the group consisting of: ridges, divots, dimples, frictional elements, grooves, channels, bumps, surface roughening, and high-friction areas.
52. The method of any one of claims 28-51, wherein said bottom surface of said band comprises surface features defining diagonal ridges.
PCT/IL2023/050107 2022-02-01 2023-01-31 Medical line anchoring device WO2023148728A1 (en)

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US63/305,303 2022-02-01

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3059645A (en) * 1960-11-28 1962-10-23 Paul A Hasbrouck Adjustable clamp
US20110147542A1 (en) * 2009-12-07 2011-06-23 Ross Matthew Hoek Cable organizer
US20170087296A1 (en) * 2015-09-30 2017-03-30 Rolanda Florence Multiple intravenous line retention system
CN211584823U (en) * 2020-01-07 2020-09-29 赵朋飞 A bracelet for fixing transfer line
US20210244917A1 (en) * 2020-01-17 2021-08-12 Quest Medical, Inc. Tubing Management Band

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3059645A (en) * 1960-11-28 1962-10-23 Paul A Hasbrouck Adjustable clamp
US20110147542A1 (en) * 2009-12-07 2011-06-23 Ross Matthew Hoek Cable organizer
US20170087296A1 (en) * 2015-09-30 2017-03-30 Rolanda Florence Multiple intravenous line retention system
CN211584823U (en) * 2020-01-07 2020-09-29 赵朋飞 A bracelet for fixing transfer line
US20210244917A1 (en) * 2020-01-17 2021-08-12 Quest Medical, Inc. Tubing Management Band

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