Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/02—Holding devices, e.g. on the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/02—Holding devices, e.g. on the body
  • A61M2025/024—Holding devices, e.g. on the body having a clip or clamp system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/02—Holding devices, e.g. on the body
  • A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/02—Holding devices, e.g. on the body
  • A61M2025/028—Holding devices, e.g. on the body having a mainly rigid support structure

Definitions

• the present disclosure relates to a securement device for a catheter assembly, a kit including the securement device, and a method of using the securement device.
• Catheter assemblies may be used for various purposes, such as feeding, air supply, and/or liquid removal.
• catheter assemblies may be used to administer medications and fluids to a patient.
• Such catheter assemblies typically include a cannula that is inserted into a patient’s skin at an insertion site.
• Catheter assemblies may need to be secured to a skin of the patient to prevent movement of the catheter assemblies.
• the catheter assemblies may be secured to the skin of the patient to prevent the catheter assemblies from being pulled out, or otherwise move in ways that may adversely affect functioning of the catheter assemblies.
• Catheter assemblies are generally secured to the skin of the patient using conventional securement units, such as, tapes, patches, and sutures.
• conventional securement units may not properly secure the catheter assemblies to the skin.
• securement units may not adequately stabilize the catheter assemblies, which may cause undesirable movement of the catheter assemblies during use.
• conventional securement units may result in various complications, such as dislodgment and accidental removal of the catheter assemblies from the skin of the patient, phlebitis, extravasation/infiltration, leakage, occlusion, and bloodstream infections.
• Securement units such as, tapes or patches may allow partial or micro movement of the catheter assembly which can lead to discomfort for the patients. Further, use of sutures to secure the catheter assemblies to the skin may lead to suture related infections and complications.
• a clinician may have to access the insertion site of the cannula, for example, to perform a maintenance procedure around the insertion site.
• conventional securement units may not allow access to the area around the insertion site. Further, clinicians may have to remove the securement units for accessing the insertion site, which may cause the cannula to piston and may warrant additional efforts in stabilizing the cannula and other components of the catheter assembly.
• an improved securement device may be needed to overcome the abovementioned challenges of conventional securement units and methods.
• the present disclosure relates to a securement device for a catheter assembly, a kit including the securement device, and a method of using the securement device.
• the present disclosure provides a securement device for a catheter assembly having a catheter hub and a cannula configured to be inserted into a skin of a patient at an insertion site.
• the securement device includes a base assembly configured to be detachably secured to the skin of the patient.
• the base assembly includes a base mount.
• the base assembly further includes a slider track fixedly coupled to the base mount and including a first coupling feature.
• the first coupling feature includes a first arcuate shape along a length of the first coupling feature.
• the securement device further includes a hub assembly slidably coupled to the base assembly.
• the hub assembly includes a hub slider including a second coupling feature complementary to the first coupling feature.
• the second coupling feature includes a second arcuate shape along a length of the second coupling feature similar to the first arcuate shape of the slider track.
• the length of the second coupling feature is less than the length of the first coupling feature.
• the second coupling feature at least partially and slidably engages with the first coupling feature, such that the hub slider is slidable relative to the base assembly along the slider track.
• the hub assembly further includes a hub base fixedly coupled to and disposed on the hub slider opposite to the slider track.
• the hub base is configured to be detachably secured to the catheter hub and the cannula. Further, the hub assembly is slidably movable relative to the base assembly to a desired position along the slider track.
• the present disclosure provides a kit.
• the kit includes a catheter assembly including a catheter hub, at least one lumen extending from the catheter hub, and a cannula extending from the catheter hub opposite to the at least one lumen and configured to be inserted into a skin of a patient at an insertion site.
• the kit further includes a securement device for the catheter assembly.
• the securement device includes a base assembly configured to be detachably secured to the skin of the patient.
• the base assembly includes a base mount.
• the base assembly further includes a slider track fixedly coupled to the base mount and including a first coupling feature.
• the first coupling feature includes a first arcuate shape along a length of the first coupling feature.
• the securement device further includes a hub assembly slidably coupled to the base assembly.
• the hub assembly includes a hub slider including a second coupling feature complementary to the first coupling feature.
• the second coupling feature includes a second arcuate shape along a length of the second coupling feature similar to the first arcuate shape of the slider track. The length of the second coupling feature is less than the length of the first coupling feature.
• the second coupling feature at least partially and slidably engages with the first coupling feature, such that the hub slider is slidable relative to the base assembly along the slider track.
• the hub assembly further includes a hub base fixedly coupled to and disposed on the hub slider opposite to the slider track.
• the hub base is configured to be detachably secured to the catheter hub and the cannula. Further, the hub assembly is slidably movable relative to the base assembly to a desired position along the slider track.
• the present disclosure provides a method of using a securement device with a catheter assembly having a catheter hub and a cannula inserted into a skin of a patient at an insertion site.
• the securement device includes a base assembly configured to be detachably secured to the skin of the patient, and a hub assembly slidably coupled to the base assembly and configured to be detachably secured to the catheter hub and the cannula.
• the base assembly includes a slider track.
• the hub assembly includes a hub slider slidable along the slider track of the base assembly.
• the method includes detachably securing the base assembly to the skin of the patient.
• the method further includes detachably securing the catheter hub and the cannula of the catheter assembly to the hub assembly.
• the method further includes sliding the hub assembly relative to the base assembly to a desired position along the slider track. An exposed length of the cannula between the hub assembly and the insertion site remains substantially constant at any position of the hub assembly along the slider track.
• the method further includes performing a maintenance procedure proximal to the insertion site upon positioning the hub assembly at the desired position
• FIG. 1 A illustrates a schematic perspective view of a securement device secured to a skin of a patient, according to an embodiment of the present disclosure
• FIG. IB illustrates a schematic cross-sectional side view of abase assembly of the securement device of FIG. 1A, according to an embodiment of the present disclosure
• FIG. 2 illustrates a schematic perspective view of a slider track coupled with a hub slider of the securement device of FIG. 1A, according to an embodiment of the present disclosure
• FIG. 3A illustrates a schematic cross-sectional view of a portion of the securement device of FIG. 1 A, according to an embodiment of the present disclosure
• FIG. 3B illustrates a schematic cross-sectional view of the hub slider coupled to the slider track, according to an embodiment of the present disclosure
• FIG. 4 illustrates an exploded view of a hub assembly of the securement device of FIG. 1 A, according to an embodiment of the present disclosure
• FIG. 5 illustrates a schematic perspective view of the securement device of FIG. 1A wherein the hub assembly is disposed at a central position, according to an embodiment of the present disclosure
• FIG. 6 illustrates a schematic perspective view of the securement device of FIG. 1A wherein the hub assembly is disposed at a different position, according to an embodiment of the present disclosure
• FIG. 7 illustrates a schematic perspective view of another design of a slider track and a hub slider that may be associated with the securement device of FIG. 1A, according to another embodiment of the present disclosure
• FIG. 8 illustrates a block diagram of a kit including the securement device of FIG. 1A, according to an embodiment of the present disclosure.
• FIG. 9 illustrates a flowchart for a method of using the securement device of FIG. 1A, according to an embodiment of the present disclosure.
• first and second are used as identifiers. Therefore, such terms should not be construed as limiting of this disclosure.
• the terms “first” and “second” when used in conjunction with a feature or an element can be interchanged throughout the embodiments of this disclosure.
• the terms “layer”, “sheet”, and “dressing”, or variations thereof, are used to describe an article having a thickness that is small relative to its length and width.
• polymer refers to both materials prepared from one monomer such as a homopolymer or to materials prepared from two or more monomers such as a copolymer, terpolymer, or the like.
• polymerize refers to the process of making a polymeric material that can be a homopolymer, copolymer, terpolymer, or the like.
• copolymer refers to a polymeric material prepared from at least two different monomers.
• insertion site refers to a location at which a cannula of a catheter is inserted into a skin of a patient.
• the term “maintenance procedure” refers generally to a procedure that includes cleaning and/or sanitizing of a skin of a patient proximal to an insertion site.
• the maintenance procedure may be carried out by a medical practitioner at regular intervals during, for example, an intravenous therapy.
• the term “pistoning” or “pistoning movement” refers to a movement of a cannula of a catheter relative to an insertion site.
• a distal end of a catheter or a cannula may be located at any desired anatomical site including, as non-limiting examples, within the lumens of veins and/or arteries, within the atria and the ventricles of the heart, within the ventral body cavity, within the spinal canal, within the subarachnoid space, within the intracranial space, and within fat and/or muscle tissues.
• Catheter assemblies may be used for administering medications and fluids to a patient, air supply, and/or liquid removal. Such catheter assemblies may need to be secured to a skin of the patient to prevent movement of the catheter assemblies. For example, the catheter assemblies may be secured to the skin of the patient to prevent the catheter assemblies from being pulled out, or otherwise move in ways that may adversely affect a functioning of the catheter assemblies.
• catheter assemblies typically include a cannula that is inserted into a patient’s skin at an insertion site.
• Conventional securement units such as, tapes, patches, and sutures may not properly secure the catheter assemblies to the skin of the patient. Specifically, conventional securement units may not properly stabilize the catheter assemblies, thereby allowing undesirable movement of the catheter assemblies during use. In some cases, use of conventional securement units may result in various complications, such as, dislodgment and accidental removal of the catheter assemblies from the skin of the patient, phlebitis, extravasation, occlusion/infiltration, leakage, and bloodstream infections. Securement units, such as, tapes or patches may allow partial or micro movement of the catheter assembly which can lead to discomfort for the patients. Further, use of sutures to secure the catheter assemblies to the skin may lead to suture related infections and complications.
• a clinician may have to access the insertion site, for example, to perform a maintenance procedure around the insertion site.
• conventional securement units may not allow access to the area around the insertion site. More particularly, clinicians may have to remove the securement units for accessing the insertion site, which may cause the cannula to piston and may warrant additional efforts in stabilizing the cannula or other parts of the catheter assemblies.
• an improved securement device may be needed to overcome the abovementioned challenges of conventional securement units and methods.
• the present disclosure provides a securement device for a catheter assembly having a catheter hub and a cannula configured to be inserted into a skin of a patient at an insertion site.
• the securement device includes a base assembly configured to be detachably secured to the skin of the patient.
• the base assembly includes a base mount.
• the base assembly further includes a slider track fixedly coupled to the base mount and including a first coupling feature.
• the first coupling feature includes a first arcuate shape along a length of the first coupling feature.
• the securement device further includes a hub assembly slidably coupled to the base assembly.
• the hub assembly includes a hub slider including a second coupling feature complementary to the first coupling feature.
• the second coupling feature includes a second arcuate shape along a length of the second coupling feature similar to the first arcuate shape of the slider track.
• the length of the second coupling feature is less than the length of the first coupling feature.
• the second coupling feature at least partially and slidably engages with the first coupling feature, such that the hub slider is slidable relative to the base assembly along the slider track.
• the hub assembly further includes a hub base fixedly coupled to and disposed on the hub slider opposite to the slider track.
• the hub base is configured to be detachably secured to the catheter hub and the cannula. Further, the hub assembly is slidably movable relative to the base assembly to a desired position along the slider track.
• the present disclosure also relates to a kit including the securement device, and a method of using the securement device.
• the slider track and the hub slider may together allow movement of the hub assembly relative to the base assembly.
• clinicians may be able to easily access the insertion site for maintenance procedures, such as, cleaning procedures.
• the design of the slider track and the slider channel may prevent pistoning of the cannula when the hub assembly is moved to different position along the slider track.
• the securement device allows easy and quick positioning of the hub assembly at any desired position based on a sliding force applied on the hub assembly.
• a minimum distance defined between the insertion site and the hub base is constant at any position of the hub assembly along the slider track.
• the securement device eliminates any possibility of pistoning/movement of the cannula when the hub assembly is being moved.
• the securement device secures the catheter assembly firmly onto the skin of the patient.
• the securement device may firmly secure various components (such as the catheter hub, the lumens, and the cannula) of the catheter assembly to the skin of the patient.
• the securement device may prevent movement of the catheter assembly and eliminates requirements of any additional tapes, patches, or sutures. It should be noted that once the securement device is placed on the patient’s skin, no additional dressing may be required.
• a base of the base assembly may be removably secured to the skin of the patient.
• the base includes one or more pull tabs that may be gripped by a user, such as, a clinician/medical personnel. The pull tabs may be pulled to detach the base from the skin.
• An adhesive layer firmly secures the base on the skin of the patient.
• the adhesive layer may include a stretch release adhesive such that, based on a pulling of the pull tabs, the adhesive layer loses its adhesion property. Subsequently, the base can be released easily to remove the securement device from the skin of the patient without causing discomfort to the patient.
• the securement device may prevent dislodgement and accidental removal of the catheter assembly from the skin of the patient.
• the securement device of the present disclosure may firmly secure the catheter assembly to the skin of the patient, may inhibit undesirable movement of the catheter assembly, may prevent infection at the insertion site, may facilitate easy removal of the securement device after use, and may allow clinicians to easily access the area around the insertion site without removing the securement device or pistoning of the cannula.
• FIG. 1A illustrates a schematic perspective view of a securement device 100 for a catheter assembly 10, according to an embodiment of the present disclosure.
• the catheter assembly 10 is disposed on a skin 12 of a patient 14.
• the catheter assembly 10 includes a catheter hub 16 and a cannula 18 configured to be inserted into the skin 12 of the patient 14 at an insertion site 20. Further, the cannula 18 is at least partially received within the catheter hub 16.
• the catheter assembly 10 further includes at least one lumen 22 at least partially received within the catheter hub 16.
• the at least one lumen 22 include three lumens 22.
• the catheter assembly 10 is a triple lumen catheter assembly 10.
• a number of the lumens 22 may vary based on desired application and/or infusion attributes.
• the lumens 22 are fluidly connected with the cannula 18.
• the catheter hub 16 includes a pair of opposing wings 24 and one ormore holes 26. Specifically, in the illustrated embodiment of FIG. 1A, the catheter hub 16 includes a corresponding hole 26 on each of the pair of opposing wings 24.
• the catheter assembly 10 may include a central venous catheter (CVC).
• CVC central venous catheter
• the CVC may be referred to as a central line, a central venous line, or a central venous access catheter.
• the CVC may be used to access large, centrally located veins (not shown), which is often required for critically ill patients, for patients requiring prolonged intravenous therapies for reliable vascular access, and to administer fluids that may harm smaller peripheral veins.
• the cannula 18 may be inserted into veins located at a neck (e.g., an internal jugular vein), into veins located at a chest (e.g., a subclavian vein or axillary vein), or into veins located at a groin (e.g., a femoral vein) of the patient 14.
• the catheter assembly 10 may include a peripherally inserted central catheter (PICC).
• the PICC may be suitable for insertion into veins located at an arm of the patient 14.
• the catheter assembly 10 may include any suitable type of catheter, which may be selected based on desired application attributes.
• the catheter assembly 10 may be used to administer an intravenous therapy (e.g., medication or fluids for parenteral nutrition), to obtain blood for analysis, and/or to provide an access point for bloodbased treatments, such as, dialysis or apheresis.
• the catheter assembly 10 may further be used to measure one or more properties of the blood (e.g., a "central venous oxygen saturation"), administer fluid or blood products for a large volume resuscitation, and/or measure a central venous pressure.
• the securement device 100 includes a base assembly 102 configured to be detachably secured to the skin 12 of the patient 14.
• the base assembly 102 includes a base mount 104.
• the base mount 104 has a substantially tapered shape. Specifically, the base mount 104 tapers towards the insertion site 20.
• the base assembly 102 further includes a slider track 106 fixedly coupled to the base mount 104.
• the slider track 106 includes a first coupling feature 108.
• the first coupling feature 108 includes a first arcuate shape 110 along a length LI (shown in FIG. 2) of the first coupling feature 108.
• the length LI is embodied as a curved length herein.
• the securement device 100 further includes a hub assembly 112 (shown in FIGS. 1A and 4) slidably coupled to the base assembly 102.
• the hub assembly 112 is slidably movable relative to the base assembly 102 to a desired position along the slider track 106.
• the hub assembly 112 includes a hub slider 114 (shown in FIGS. 2, 3A, 3B, and 4).
• the slider track 106 and the hub slider 114 may together allow movement of the hub assembly 112 relative to the base assembly 102.
• clinicians may be able to easily access the insertion site 20 for maintenance procedures, such as, cleaning procedures. Specifically, clinicians may be able to access a 360 degrees area around the insertion site 20.
• the design of the slider track 106 and the hub slider 114 may prevent pistoning of the cannula 18 when the hub assembly 112 is moved to any position along the slider track 106.
• the hub assembly 112 further includes a hub base 116 fixedly coupled to and disposed on the hub slider 114 opposite to the slider track 106.
• the hub base 116 is configured to be detachably secured to the catheter hub 16 and the cannula 18.
• the base assembly 102 includes a base 118.
• the base 118 is substantially oval shaped.
• the base 118 may be a passive dressing. In other words, in some embodiments, the base 118 may be nonocclusive. However, the base 118 may be an interactive dressing. In other words, in some embodiments, the base 118 may be semi-occlusive or occlusive. In some embodiments, the base 118 may function as a barrier against penetration of bacteria. In some embodiments, the base 118 may maintain hydration of an area of the skin 12 to which the base 118 is removably secured and may reduce infection at the area of the skin 12 to which the base 118 is removably secured.
• the base 118 may include a stretchable polymeric material.
• the base 118 may be made of a stretchable material that may conform to undulated surfaces (e.g., the skin 12 of the patient 14). Therefore, in some embodiments, the base 118 may be configured to exhibit high elasticity. In some embodiments, the base 118 may have a high tensile strength, a low elastic recovery, and a high elongation at break.
• the base 118 may include at least one of a polymeric film, a polymeric foam, a polymeric hydrocolloid, and a polymeric alginate.
• the base 118 may include polyolefins, such as polyethylene, including high density polyethylene, low density polyethylene, linear low density polyethylene, and linear ultra-low density polyethylene, polypropylene, and polybutylenes; vinyl copolymers, such as polyvinyl chlorides, both plasticized and unplasticized, and polyvinyl acetates; olefinic copolymers, such as ethylene/methacrylate copolymers, ethylene/vinyl acetate copolymers, acrylonitrile - butadiene-styrene copolymers, and ethylene propylene copolymers; acrylic polymers and copolymer; and combinations thereof.
• the base 118 may be in a form of single or multi-layer films, non-woven films, porous films, foam-like films, and combinations thereof. In some embodiments, the base 118 may be fabricated using any suitable method of film forming, such as, extrusion, co-extrusion, solvent casting, foaming, non-woven technology, and the like.
• the base 118 includes one or more pull tabs 120 that may be gripped by a user, such as a clinician or a medical professional.
• the pull tabs 120 may be pulled to detach the base 118 from the skin 12.
• the pull tabs 120 allow gripping of the base 118 for application and removal of the securement device 100 and also allow the clinician or any other medical professional to peel-off a release liner 122 (shown in FIG. IB) for application of the securement device 100 onto the skin 12 of the patient 14.
• the base 118 may be stretched by gripping and pulling the pull tabs 120.
• the base 118 may be easily removed from the skin 12 of the patient 14 by stretching the base 118 based on gripping of the pull tabs 120.
• the pull tabs 120 are disposed along a portion of a perimeter of the base 118.
• the base 118 includes two pull tabs 120 disposed at opposing ends 119, 121 of the base 118.
• the pull tabs 120 are adhesive free zones, such that the pull tabs 120 are not attached to the skin 12 of the patient 14.
• the pull tabs 120 may include markings, such as, arrows that indicate a direction along which the pull tabs 120 need to be pulled for removal of the securement device 100.
• the markings may also include text, such as, “PULL” in addition to the arrows.
• FIG. IB illustrates a schematic cross-sectional view of the base assembly 102.
• the base 118 includes a first major surface 126 fixedly coupled to the base mount 104 opposite to the slider track 106, and a second major surface 128 opposite to the first major surface 126.
• the base assembly 102 further includes the release liner 122. In some embodiments, the release liner 122 does not cover the pull tabs 120.
• the base assembly 102 further includes an adhesive layer 130 at least partially disposed on the second major surface 128 and configured to detachably secure the base assembly 102 to the skin 12 of the patient 14. It should be noted that the pull tabs 120 are free of the adhesive layer 130.
• the adhesive layer 130 includes a stretch release adhesive.
• an adhesive strength of the stretch-release adhesive may be less than a cohesive strength of the stretch-release adhesive, such that upon stretching of the base 118, adhesion capabilities of the stretchrelease adhesive may essentially disappear. Specifically, a tack of the stretch release adhesive may be lost upon stretching of the base 118.
• the adhesive layer 130 loses its adhesion property. Subsequently, the base 118 can be released easily to remove the securement device 100 from the skin 12 of the patient 14.
• the base assembly 102 may be easily removed from the skin 12 of the patient 14 without causing discomfort to the patient 14. Moreover, the base assembly 102 may prevent dislodgement and accidental removal of the catheter assembly 10 from the skin 12 of the patient 14.
• the slider track 106 includes a pair of end walls 132 circumferentially spaced apart from each other and disposed at respective opposing ends 134, 136 of the slider track 106.
• Each of the pair of end walls 132 is configured to engage with the hub slider 114 to limit a sliding movement of the hub slider 114 at the respective opposing end 134, 136 of the slider track 106.
• the slider track 106 has a first center of curvature Cl.
• the hub assembly 112 includes the hub slider 114.
• the hub slider 114 includes a second coupling feature 138 complementary to the first coupling feature 108.
• the second coupling feature 138 includes a second arcuate shape 140 along a length L2 of the second coupling feature 138 similar to the first arcuate shape 110 of the slider track 106.
• the length L2 of the second coupling feature 138 is less than the length LI of the first coupling feature 108.
• the length L2 is embodied as a curved length herein.
• the second coupling feature 138 at least partially and slidably engages with the first coupling feature 108, such that the hub slider 114 is slidable relative to the base assembly 102 along the slider track 106. Further, the second coupling feature 138 at least partially and frictionally engages with the first coupling feature 108, such that the hub slider 114 is stationary relative to the slider track 106 upon removal of a sliding force Fl, F2 on the hub assembly 112. It should be noted that the sliding force F 1 is applied in a direction that is opposite to a direction in which the sliding force F2 is applied.
• the securement device 100 may allow easy and quick positioning of the hub assembly 112 at any desired position based on the sliding force Fl, F2 applied on the hub assembly 112.
• the hub slider 114 has a second center of curvature C2 coinciding with the first center of curvature Cl of the slider track 106.
• the base mount 104 includes an arcuate guide rail 142 spaced apart from the slider track 106.
• the hub base 116 includes an engaging feature 144 configured to slidably engage with the guide rail 142 of the base mount 104. Upon sliding of the hub slider 114 relative to the slider track 106, the engaging feature 144 correspondingly slides along the guide rail 142.
• the engaging feature 144 is embodied as a projection herein that extends from the hub base 116.
• the engaging feature 144 is arcuate in shape and corresponds to a shape of the guide rail 142.
• the engaging feature 144 may include a groove or slot defined by the hub base 116 instead of the projection.
• the base mount 104 may also include one or more markings that show a direction along which the hub slider 114 may be moved for positioning the hub assembly 112 at a desired position.
• FIGS. 3A and 3B illustrate a cross-sectional view illustrating the hub slider 114 coupled to the slider track 106.
• the first coupling feature 108 includes a first portion 146 fixedly coupled to and extending from the base mount 104.
• the first portion 146 includes a first elongate member 148 and a second elongate member 150 extending orthogonally from the first elongate member 148.
• the first coupling feature 108 includes a second portion 152 coupled to and substantially orthogonal to the first portion 146.
• the second portion 152 is spaced apart from the base mount 104.
• the second portion 152 has a tapered shape.
• the second portion 152 is substantially parallel to the first elongate member 148 and extends orthogonally relative to the second elongate member 150.
• the second elongate member 150 connects the first elongate member 148 to the second portion 152.
• the first coupling feature 108 may include any other design or arrangement of components, without any limitations.
• the second coupling feature 138 includes a base portion 154 fixedly coupled to the hub base 116. As shown in FIG. 3B, the second coupling feature 138 also includes a pair of side portions 156 coupled to and extending from respective opposing longitudinal ends 158, 160 of the base portion 154. Each of the pair of side portions 156 is substantially orthogonal to the base portion 154. The second coupling feature 138 further includes a pair of retaining portions 162 substantially parallel to the base portion 154. Each of the pair of retaining portions 162 is coupled to and extends from a respective side portion 156 from the pair of side portions 156 distal to the base portion 154.
• the base portion 154, the pair of side portions 156, and the pair of retaining portions 162 define a slot 163 therebetween.
• the slot 163 at least partially receives the second portion 152 of the first coupling feature 108 therein, such that the second portion 152 at least partially and slidably engages with the base portion 154, the pair of side portions 156, and the pair of retaining portions 162.
• the second coupling feature 138 may include any other design or arrangement of components, without any limitations.
• the hub base 116 defines a first end 164 and a second end 166 opposite the first end 164. Further, the hub base 116 includes a hub receiving portion 168 configured to detachably secure the catheter hub 16 therein.
• the hub receiving portion 168 defines a base surface 170.
• the hub base 116 includes one or more stabilization lugs 172 extending from the base surface 170.
• the hub base 116 includes two stabilization lugs 172.
• the stabilization lugs 172 are disposed in a manner such that the stabilization lugs 172 can together accommodate the catheter hub 16 therein.
• the stabilization lugs 172 may engage with the catheter hub 16 to secure the catheter hub 16 within the hub receiving portion 168.
• the stabilization lugs 172 may engage with the catheter hub 16 to restrict any movement of the catheter hub 16 relative to the base surface 170. In some embodiments, the stabilization lugs 172 may align with the holes 26 in the catheter hub 16 for receipt of the stabilization lugs 172 within the holes 26.
• the hub receiving portion 168 further includes a peripheral wall 174 separating the hub receiving portion 168 from a cannula receiving portion 176.
• the peripheral wall 174 extends orthogonally from the base surface 170.
• the peripheral wall 174 and the base surface 170 together define a receiving space 178 within the hub receiving portion 168, such that the catheter hub 16 is received within the receiving space 178 and rests on the base surface 170.
• the peripheral wall 174 includes a locking member 180 at the first end 164 of the hub base 116.
• the peripheral wall 174 further includes a cannula opening 182 extending therethrough.
• the cannula opening 182 is configured to at least partially receive the cannula 18 therethrough.
• the peripheral wall 174 further includes at least one lumen opening 184 extending therethrough and disposed opposite to the cannula opening 182.
• the at least one lumen opening 184 is configured to at least partially receive the at least one lumen 22 of the catheter assembly 10 therethrough.
• the peripheral wall 174 includes three lumen openings 184 herein. However, a total number of the lumen openings 184 may vary based on the number of lumens 22.
• the hub base 116 further includes the cannula receiving portion 176 disposed adjacent to the hub receiving portion 168 and configured to at least partially and detachably secure the cannula 18 therein.
• the cannula receiving portion 176 extends from the hub receiving portion 168.
• the cannula receiving portion 176 includes a first slot 186 configured to at least partially receive the cannula 18 therein.
• the hub assembly 112 further includes a hub cap 188 configured to be removably coupled to the hub receiving portion 168 of the hub base 116.
• the hub cap 188 is illustrated in an open position in FIG. 1A and in a closed position in FIG. 5.
• the hub cap 188 is pivotally coupled to the hub receiving portion 168 at the first end 164 of the hub base 116 and pivotally movable relative to the hub receiving portion 168 independent of a cannula cap 190.
• the hub base 116 includes a living hinge 192 that pivotally couples the hub cap 188 with the hub receiving portion 168.
• the hub cap 188 is removably coupled with the hub receiving portion 168 at the second end 166 of the hub base 116. Specifically, the hub cap 188 defines a cavity (not shown) that receives the locking member 180 of the hub receiving portion 168 to lock the hub cap 188 with the hub receiving portion 168. It should be noted that any other technique may be used to removably couple the hub cap 188 with the hub receiving portion 168.
• the hub base 116 includes the cannula cap 190 separate from the hub cap 188 and configured to be removably coupled to the cannula receiving portion 176 of the hub base 116.
• the cannula cap 190 is illustrated in an open position in FIG. 1A and in a closed position in FIG. 5. As the cannula cap 190 is independent from the hub cap 188, users may be able to access the catheter hub 16 without opening the hub cap 188.
• the cannula cap 190 is coupled with the cannula receiving portion 176, the cannula cap 190 and the cannula receiving portion 176 detachably secure the cannula 18 therebetween.
• the cannula 18 remains detachably secured to the cannula receiving portion 176 upon detachment of the hub cap 188 from the hub receiving portion 168 and removal of the catheter hub 16 from the hub receiving portion 168.
• the cannula cap 190 is pivotally coupled to the cannula receiving portion 176 at the first end 164 of the hub base 116 and pivotally movable relative to the cannula receiving portion 176 independent ofthe hub cap 188.
• the cannula cap 190 is removably coupled with the cannula receiving portion 176 at the second end 166 of the hub base 116.
• the cannula cap 190 includes a second slot 194. Upon removable coupling of the cannula cap 190 to the cannula receiving portion 176, the second slot 194 is at least partially aligned with the first slot 186. Further, upon insertion of the cannula 18 in the first slot 186 and removable coupling of the cannula cap 190 to the cannula receiving portion 176, the first slot 186 and the second slot 194 collectively and at least partially receive the cannula 18 therebetween, such that the cannula 18 is detachably secured to the cannula receiving portion 176.
• the securement device 100 includes a first sleeve 196 at least partially received within the first slot 186 and a second sleeve 198 at least partially received within the second slot 194.
• first sleeve 196 and the second sleeve 198 frictionally engages with the cannula 18 (see FIG. 1A), such that the cannula 18 is detachably secured between the cannula receiving portion 176 and the cannula cap 190.
• Such a frictional engagement of the cannula 18 may prevent any unintentional removal ofthe cannula 18 from the cannula receiving portion 176.
• FIGS. 5 and 6 illustrate schematic perspective views wherein each ofthe hub cap 188 and the cannula cap 190 are in the closed positions.
• FIG. 5 illustrates the hub assembly 112 at a central position, i.e., when the hub assembly 112 is centrally located with respect to the slider track 106.
• the hub assembly 112 when the sliding force Fl is applied on the hub assembly 112, the hub assembly 112 may be disposed proximal to the end 119 of the base 118 and farther from the end 121 of the base 118.
• the sliding force F2 is applied on the hub assembly 112, the hub assembly 112 may be disposed proximal to the end 121 and farther from the end 119.
• the hub assembly 112 is rotatable about a pivot axis P 1 passing through the first center of curvature Cl upon sliding of the hub slider 114 (see FIGS. 2, 3A, 3B, and 4) along the slider track 106.
• each of the first center of curvature Cl and the second center of curvature C2 is disposed at the insertion site 20, such that the pivot axis P 1 passes through the insertion site 20.
• a minimum distance DI defined between the pivot axis Pl and the hub base 116 is constant at any position of the hub assembly 112 along the slider track 106.
• an exposed length U3 of the cannula 18 between the hub base 116 and the insertion site 20 is substantially constant at any position of the hub assembly 112 along the slider track 106.
• the securement device 100 eliminates any possibility of pistoning/movement of the cannula 18 as the hub assembly 112 is moved to different positions.
• the securement device 100 secures the catheter assembly 10 firmly onto the skin 12 of the patient 14. Specifically, the securement device 100 may firmly secure various components (such as the catheter hub 16, the lumens 22, and the cannula 18 as shown in FIG. 1A) of the catheter assembly 10 onto the skin 12 of the patient 14. Further, the securement device 100 may inhibit undesirable movement of the catheter assembly 10. Consequently, the securement device 100 may prevent various complications that may otherwise occur due to micro-movement of the catheter assembly 10. Moreover, the securement device 100 may eliminate requirements of any additional tapes, patches, or sutures for securement of the catheter assembly 10. Additionally, the securement device 100 may facilitate easy removal of the securement device 100 after use.
• various components such as the catheter hub 16, the lumens 22, and the cannula 18 as shown in FIG. 1A
• the sliding of the hub assembly 112 relative to the base assembly 102 may allow clinicians to easily access the area around the insertion site 20 without removing the securement device 100.
• clinicians may access 360 degree area around the insertion site 20 without removing the securement device 100.
• the securement device 100 may further prevent infection at the insertion site 20.
• the securement device 100 may provide improved comfort to the patient 14 during use.
• FIG. 7 illustrates another embodiment of the present disclosure. Specifically, FIG. 7 illustrates a slider track 706 substantially similar to the slider track 106 explained in relation to FIGS. 1A to 4, and a hub slider 714 substantially similar to the hub slider 114 explained in relation to FIGS. lA to 4.
• the slider track 706 includes a first coupling feature 708 that is substantially similar to the first coupling feature 108 (see FIGS. 1A and 2).
• the hub slider 714 includes a second coupling feature 738 that is substantially similar to the second coupling feature 138 (see FIG. 2).
• the slider track 706 includes a plurality of locking portions 701 disposed on the first coupling feature 708 at a corresponding plurality of locking positions along a length L4 of the first coupling feature 708.
• Each of the plurality of locking portions 701 is configured to removably engage with the second coupling feature 738 to lock the hub slider 714 with the slider track 706 at a corresponding locking position.
• the hub assembly 112 (see FIGS. 1A, 4, 5, and 6) is configured to be secured at a selected one of the plurality of locking positions.
• the locking portions 701 may allow locking of the hub assembly 112 at any one of the plurality of locking positions.
• the plurality of locking positions may include three discrete locking positions, without any limitations thereto.
• the hub slider 714 includes at least one opening 703 for receiving a corresponding locking portion 701 therein. . Specifically, the hub slider 714 includes a single opening 703. The opening 703 is substantially rectangular shaped. It should be noted that the slider track 706 or the hub slider 714 may include any other design or arrangement of components that may allow locking of the hub slider 714 with the slider track 706. In an alternate example, the locking portions 701 may be disposed on the second coupling feature 738 of the hub slider 714.
• FIG. 8 illustrates a schematic block diagram of a kit 200 according to an embodiment of the present disclosure.
• the kit 200 includes the catheter assembly 10.
• the catheter assembly 10 includes the catheter hub 16, the at least one lumen 22 extending from the catheter hub 16, and the cannula 18 extending from the catheter hub 16 opposite to the at least one lumen 22 and configured to be inserted into the skin 12 of the patient 14 at the insertion site 20.
• the kit 200 further includes the securement device 100 as explained with reference to FIGS. 1A to 6.
• the kit 200 may further include gloves (not shown).
• the kit 200 may further include a sterilizing material (not shown).
• the kit 200 may further include a cloth or other absorbent material (not shown).
• the kit 200 may further include cleaning articles (not shown), such as cleaning cloth, cotton balls, cotton swabs, and the like.
• the kit 200 may be available to clinicians or medical professionals for use in a sterilized package.
• the clinician may remove the release liner 122 (see FIG. IB) and detachably attach the securement device 100 onto the skin 12 (see FIG. 1A).
• the catheter assembly 10 may therefore be secured and stabilized.
• the clinician may further apply a window dressing over the insertion site 20 to provide extra protection from infection at the insertion site 20.
• FIG. 9 illustrates a flowchart for a method 900 of using the securement device 100 with the catheter assembly 10 having the catheter hub 16 and the cannula 18 inserted into the skin 12 of the patient 14 at the insertion site 20.
• the securement device 100 including the base assembly 102 configured to be detachably secured to the skin 12 of the patient 14, and the hub assembly 112 slidably coupled to the base assembly 102 and configured to be detachably secured to the catheter hub 16 and the cannula 18.
• the base assembly 102 includes the slider track 106.
• the hub assembly 112 includes the hub slider 114 that is slidable along the slider track 106 of the base assembly 102.
• the base assembly 102 is detachably secured to the skin 12 of the patient 14. Further, detachably securing the base assembly 102 to the skin 12 of the patient 14 includes detachably bonding the base 118 of the base assembly 102 to the skin 12 of the patient 14 via an adhesive.
• the catheter hub 16 and the cannula 18 of the catheter assembly 10 are detachably secured to the hub assembly 112. Further, detachably securing the cannula 18 of the catheter assembly 10 to the hub assembly 112 includes inserting the catheter hub 16 within the hub base 116 of the hub assembly 112. Moreover, detachably securing the cannula 18 of the catheter assembly 10 to the hub assembly 112 further includes removably coupling the hub cap 188 to the hub base 116, such that the catheter hub 16 is secured between the hub base 116 and the hub cap 188.
• detachably securing the cannula 18 of the catheter assembly 10 to the hub assembly 112 further includes inserting the cannula 18 in the first slot 186 of the cannula receiving portion 176 of the hub assembly 112.
• the cannula receiving portion 176 is disposed adjacent to the hub base 116.
• detachably securing the cannula 18 of the catheter assembly 10 to the hub assembly 112 further includes removably coupling the cannula cap 190 to the cannula receiving portion 176, such that the first slot 186 of the cannula receiving portion 176 and the second slot 194 of the cannula cap 190 collectively and at least partially receive the cannula 18 therebetween.
• the hub assembly 112 is slid relative to the base assembly 102 to the desired position along the slider track 106.
• the exposed length L3 of the cannula 18 between the hub assembly 112 and the insertion site 20 remains substantially constant at any position of the hub assembly 112 along the slider track 106.
• the maintenance procedure is performed proximal to the insertion site 20 upon positioning the hub assembly 112 at the desired position. Further, the catheter hub 16 is removed from the hub base 116 while the cannula 18 is still secured to the cannula receiving portion 176. Furthermore, removing the catheter hub 16 from the hub base 116 includes detaching the hub cap 188 from the hub base 116 while the cannula cap 190 is still coupled to the cannula receiving portion 176.

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• 2023
  • 2023-10-30 EP EP23888188.2A patent/EP4615549A1/de active Pending
  • 2023-10-30 JP JP2025523839A patent/JP2025535937A/ja active Pending
  • 2023-10-30 WO PCT/IB2023/060925 patent/WO2024100492A1/en not_active Ceased
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