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WO2025058775A1 - Dispositifs de fixation de cathéter - Google Patents

Dispositifs de fixation de cathéter Download PDF

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Publication number
WO2025058775A1
WO2025058775A1 PCT/US2024/042208 US2024042208W WO2025058775A1 WO 2025058775 A1 WO2025058775 A1 WO 2025058775A1 US 2024042208 W US2024042208 W US 2024042208W WO 2025058775 A1 WO2025058775 A1 WO 2025058775A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
base
securement device
supporting member
patient
Prior art date
Application number
PCT/US2024/042208
Other languages
English (en)
Inventor
Ajay Vijay Suryavanshi
Kowshika K
Praveen NALAWADE
Shishir PRASAD
Syed FAREED AHMED
Gunasekaran KARTHIKEYAN
Mukilan BALAMURUGAN
Manjunath MANGUMALI
Mohammed Mehtab KHAN
Hemant Vilas Belsare
Original Assignee
Becton, Dickinson And Company
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 Becton, Dickinson And Company filed Critical Becton, Dickinson And Company
Publication of WO2025058775A1 publication Critical patent/WO2025058775A1/fr

Links

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
    • A61M2025/0206—Holding devices, e.g. on the body where the catheter is secured by using devices worn by the patient, e.g. belts or harnesses
    • 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
    • A61M2025/0253—Holding devices, e.g. on the body where the catheter is attached by straps, bands or the like secured by adhesives
    • 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
    • A61M2025/0253—Holding devices, e.g. on the body where the catheter is attached by straps, bands or the like secured by adhesives
    • A61M2025/026—Holding devices, e.g. on the body where the catheter is attached by straps, bands or the like secured by adhesives where the straps are releasably secured, e.g. by hook and loop-type fastening devices
    • 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
    • A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
    • A61M2025/0273—Holding devices, e.g. on the body using pads, patches, tapes or the like having slits to place the pad around a catheter puncturing site
    • 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 invention relates to medical devices, and in particular, devices for catheter securement.
  • Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular and ophthalmic procedures. In most uses, a catheter is a thin, flexible tube (soft catheter) though catheters are available in varying levels of stiffness depending on the application. Catheters can be inserted into a body cavity, duct, vessel, brain, skin or adipose tissue. Functionally, they allow drainage, administration of fluids or gases, access by surgical instruments, and also perform a wide variety of other tasks depending on the type of catheter.
  • cleaning around a catheter 12 that is secured by sutures 11 may result in incomplete (and therefore inadequate) cleaning (e.g., an area A of the patient's skin S below the catheter hub 14 that has not been cleaned), which in turn can increase the risk of central line-associated bloodstream infection (CLABSI).
  • CLABSI central line-associated bloodstream infection
  • a caretaker should avoid undue movement of the catheter (for example, tip migration, dislodgement or “pistoning” of the catheter in the insertion site may occur, which may result in the catheter shifting to the extent that the catheter is no longer correctly positioned within the vein or other structure into which it is inserted). This is particularly important for certain catheters and insertion sites, such as CVCs.
  • a caretaker may attempt to use a finger F to hold a catheter 12 in place; however, this may require a second caretaker to clean the site while the first caretaker maintains the catheter 12 in position with one hand while removing the securement device 20 with the other hand. Also, this technique is not aligned with Antiseptic Non-Touch Technique (ANTT) protocol.
  • a rolled-up dressing 25 may be used to temporarily hold a catheter 12 as a securement device 20 is replaced. However, the use of the rolled-up dressing 25 may present inconsistency (e.g., how much dressing to use).
  • a secondary securement component such as an adhesive strip 15 may be used to temporarily hold a catheter 12 in position during removal and replacement of the securement device 20.
  • This technique requires that a caretaker have the knowledge to do this and the adherence to protocol to use the adhesive strip 15. Experience has shown that this protocol is often ignored. Also, removal of the adhesive strip 15 may be difficult and/or may cause movement to the catheter 12, and in some instances the adhesive strip 15 leaves a residue on the catheter lumen after removal that can attract contaminants.
  • a catheter securement device includes a base configured to be removably secured to the skin of a patient, and a clip coupled to the base.
  • the clip is configured to grasp and firmly hold a catheter inserted into the patient and prevent inadvertent movement of the catheter at a catheter insertion site.
  • the clip includes a body having a pair of opposing elastic jaws that define a catheter receiving channel that extends from a proximal end of the body to a distal end of the body.
  • First and second arms extend outwardly from the clip body in adjacent spaced apart relationship.
  • the first and second arms when squeezed toward one another by a user (e.g., a healthcare provider/technician, caretaker, etc.), are configured to urge the jaws open such that the catheter can be positioned within the catheter receiving channel.
  • the base includes first and second legs, wherein the first leg extends from a first side of the clip body and the second leg extends from an opposite second side of the clip body.
  • the first and second legs each have an adhesive portion configured for attachment to the skin of the patient.
  • the first and second arms are each movable to a respective non-operative position such that the catheter securement device has a reduced profile.
  • the first arm and second arm each have a respective hinge (e.g., a living hinge) that is configured such that the first arm and second arm are movable to their respective non-operative positions.
  • the first arm substantially overlies the first leg when in its non-operative position
  • the second arm substantially overlies the second leg when in its non-operative position.
  • an inner wall of the catheter receiving channel includes one or more features configured to firmly grip an outer surface of a catheter positioned within the catheter receiving channel and prevent any forward or backward movement of the catheter within the catheter receiving channel.
  • an outer surface of each of the first and second arms includes one or more tactile grip features to facilitate user operation of the securement device, particularly in the presence of liquids and other foreign substances.
  • a catheter securement device includes an adhesive base configured to be removably secured to the skin of a patient, and a clip coupled to the base.
  • the clip is configured to grasp and hold a catheter inserted into the patient and prevent inadvertent movement of the catheter at a catheter insertion site.
  • a body of the clip includes a pair of opposing elastic jaws that define a tapered catheter receiving channel that extends from a proximal end of the body to a distal end of the body.
  • First and second arms extend outwardly from the body in adjacent spaced apart relationship. The first and second arms, when squeezed toward one another by a user, urge the jaws open such that the catheter can be positioned within the catheter receiving channel.
  • the body is formed from an elastomeric material.
  • an inner wall of the tapered catheter receiving channel includes one or more features configured to firmly grip an outer surface of a catheter positioned within the catheter receiving channel and prevent any forward or backward movement of the catheter within the catheter receiving channel.
  • a catheter securement device includes an elongate base having opposite end portions and an arcuate central portion between the opposite end portions.
  • a bottom surface of each of the end portions includes an adhesive portion configured to removably secure the base to the skin of a patient.
  • a catheter receiving channel is transversely secured to a bottom surface of the central portion such that the catheter receiving channel extends from a first side of the base to an opposite second side of the base. The catheter receiving channel is configured to snugly hold a catheter inserted into the patient and prevent inadvertent movement of the catheter at an insertion site.
  • a catheter securement device includes a hemostatic bandage configured to be positioned at a catheter insertion site of a patient, and an elongate base secured to the hemostatic bandage in adjacent, spaced apart relationship by at least one member.
  • the base includes opposite end portions and an arcuate central portion between the opposite end portions.
  • a bottom surface of each of the end portions includes an adhesive portion that is configured to removably secure the base to the skin of the patient.
  • a catheter receiving channel is transversely secured to a bottom surface of the central portion such that the catheter receiving channel extends from a first side of the base to an opposite second side of the base.
  • a catheter hub securement device includes a base configured to be secured to the skin of a patient, and a catheter hub supporting member overlying the base and movably secured to the base. The catheter hub supporting member is movable between a lowered position and a raised position.
  • the base and the catheter hub supporting member are in close, adjacent relationship when the catheter hub supporting member is in the lowered position, and the base and the catheter hub supporting member are in spaced apart relationship when the catheter hub supporting member is in the raised position.
  • the catheter hub supporting member includes a holder configured to receive and secure a catheter hub of a catheter that has been inserted into the patient.
  • the catheter hub supporting member is movably secured to the base by at least one collapsible member.
  • the base includes opposite first and second end portions, and the catheter hub supporting member includes opposite first and second end portions.
  • the at least one collapsible member includes a first collapsible member and a second collapsible member, wherein the first collapsible member is secured to the base first end portion and the catheter hub supporting member first end portion, and wherein the second collapsible member is secured to the base second end portion and the catheter hub supporting member second end portion.
  • the catheter hub securement device includes at least one member configured to limit a distance the catheter hub supporting member can be raised relative to the base.
  • a catheter securement device includes a base configured to be removably secured to the skin of a patient, and a catheter supporting member movably coupled to the base.
  • the catheter supporting member includes at least one catheter receiving channel configured to snugly hold a catheter inserted into the patient and prevent inadvertent movement of the catheter at a catheter insertion site.
  • the at least one catheter receiving channel includes a plurality of catheter receiving channels in adjacent spaced apart relationship.
  • the catheter supporting member is movable relative to the base between a first (i.e., lowered) position and a second (i.e., raised) position, for example by a hinge.
  • the catheter supporting member is in face-to-face contacting relationship with the base when in the lowered position, and the catheter supporting member is in spaced apart relationship with the base when in the raised position.
  • the catheter securement device also includes at least one locking member configured to removably secure the catheter supporting member to the base in the raised position.
  • the at least one locking member is a tab that is configured to be releasably secured within a recessed portion of the base to maintain the catheter supporting member in the raised position.
  • the at least one locking member includes a first locking member movably secured to a first end portion of the catheter supporting member, and a second locking member movably secured to an opposite second end portion of the catheter supporting member.
  • a catheter securement device includes a base configured to be secured to the skin of a patient, and a catheter supporting member overlying the base and movably secured to the base between a lowered position and a raised position.
  • the base and the catheter supporting member are in close, adjacent relationship when the catheter supporting member is in the lowered position, and the base and the catheter supporting member are in extended, spaced apart relationship when the catheter supporting member is in the raised position.
  • the catheter supporting member includes a holder configured to snugly hold at least one catheter therein and prevent inadvertent movement of the at least one catheter.
  • the catheter supporting member is movably secured to the base by at least one collapsible member.
  • the base includes opposite first and second end portions, and the catheter supporting member includes opposite first and second end portions.
  • the at least one collapsible member includes a first collapsible member and a second collapsible member, wherein the first collapsible member is secured to the base first end portion and the catheter supporting member first end portion, and wherein the second collapsible member is secured to the base second end portion and the catheter supporting member second end portion.
  • the catheter hub securement device includes at least one member configured to limit a distance the catheter supporting member can be raised relative to the base.
  • FIG. 1 illustrates using sutures to secure a central venous catheter line on a patient.
  • FIGS. 2A-2C illustrate inadequate site-cleaning when sutures are used to secure a central venous catheter line as shown in FIG. 1.
  • FIG. 3 illustrates a known primary catheter securement device.
  • FIGS. 4A-4E illustrate current techniques used to temporarily secure a catheter during a dressing change.
  • FIGS. 5A-5B are top perspective views of a secondary catheter securement device, according to some embodiments of the present inventive concept.
  • FIG. 5A illustrates the secondary catheter securement device with the arms in an operative, upright position
  • FIG. 5B illustrates the secondary catheter securement device with the arms in a non-operative, folded down position to reduce the profile of the secondary catheter securement device.
  • FIG. 6A illustrates the secondary catheter securement device of FIG. 5 A in use and positioned between a catheter insertion site and a proximal end of a primary catheter securement device.
  • FIG. 6B illustrates the secondary catheter securement device of FIG. 6A with the arms moved to the non-operative position to provide a reduced profile.
  • FIGS. 7A-7F schematically illustrate steps for changing the dressing for a catheter using the secondary catheter securement device of FIGS. 5A-5B, according to some embodiments.
  • FIG. 8 is a top perspective view of an alternative embodiment for the secondary catheter securement device of FIGS. 5A-5B.
  • FIG. 9 illustrates the secondary catheter securement device of FIG. 6B with adhesive bridges connecting the secondary catheter securement device with the primary catheter securement device, according to some embodiments.
  • FIG. 10A is a top perspective view of a secondary catheter securement device according to some embodiments of the present inventive concept.
  • FIG. 10B is an elevation of the secondary catheter securement device of FIG.
  • FIG. 10C is a cross-sectional view of the secondary catheter securement device of FIG. 10B taken along line 10B-10B.
  • FIG. 10D is a top perspective view of the secondary catheter securement device of FIG. 10A with an adhesive base for securing the secondary catheter securement device to the skin of a patient.
  • FIG. 11 illustrates the secondary catheter securement device of FIG. 10D in use and positioned between a catheter insertion site and a distal end of a primary catheter securement device.
  • FIGS. 12A-12D schematically illustrate steps for changing the dressing for a catheter using the secondary catheter securement device of FIGS. 10A-10D and 11, according to some embodiments.
  • FIG. 13 is an exploded perspective view of a secondary catheter securement device and a primary catheter securement device, according to some embodiments of the present inventive concept.
  • FIG. 14A is a top perspective view of the secondary catheter securement device of FIG. 13.
  • FIG. 14B is a bottom perspective view of the secondary catheter securement device of FIG. 13.
  • FIGS. 15A-15G schematically illustrate steps for changing the dressing for a catheter using the secondary catheter securement device of FIGS. 14A-14B, according to some embodiments.
  • FIG. 16 is an exploded perspective view of a secondary catheter securement device and a primary catheter hub securement device, according to some embodiments of the present inventive concept.
  • FIG. 17 is top plan view of a secondary catheter securement device, according to some embodiments of the present inventive concept.
  • FIGS. 18A-18C are top perspective views of a secondary catheter securement device, according to some embodiments of the present inventive concept.
  • FIG. 18A illustrates the secondary catheter securement device with the catheter support member in a collapsed or lowered position.
  • FIG. 18B illustrates the secondary catheter securement device of FIG. 18A with the catheter support member in a raised position.
  • FIG. 18C illustrates the secondary catheter securement device of FIG. 18B with locking members in the operative position to maintain the catheter support member in the raised position.
  • FIGS. 19A-19M schematically illustrate steps for changing the dressing for a catheter using the secondary catheter securement device of FIGS. 18A-18C, according to some embodiments.
  • FIGS. 20A-20C are top perspective views of a secondary catheter securement device, according to some embodiments of the present inventive concept.
  • FIG. 20A illustrates the catheter support member of the secondary catheter securement device in a collapsed position.
  • FIG. 20B illustrates the catheter support member of the secondary catheter securement device of FIG. 20A in a raised position.
  • FIG. 20C illustrates the catheter securement device of FIG. 20A in use and positioned adjacent the distal end of a primary catheter securement device.
  • FIGS. 21A-21G schematically illustrate steps for changing the dressing for a catheter using the catheter securement device of FIGS. 20A-20C, according to some embodiments.
  • Embodiments of the present inventive concept are directed to catheter securement solutions that help minimize catheter migration and dislodgement during the dressing change of a catheter, while also not elevating other clinical burden, for example, microbial growth, patient pain, and significant workflow impact.
  • Embodiments of the present inventive concept provide secondary catheter securement devices that are configured to hold a catheter or catheter hub near the insertion site of the catheter in a patient’s skin. The secondary catheter devices allow for 360° site cleaning without increasing the risk of catheter movement during dressing change of the catheter, such as long-dwelling IV catheters, for example, a peripherally inserted central catheter (PICC) line and a central venous catheter (CVC) line.
  • PICC peripherally inserted central catheter
  • CVC central venous catheter
  • the secondary catheter securement device 100 includes a base 110 that is configured to be removably secured to the skin of a patient, and a clip 120 coupled to the base 110.
  • the clip 120 is configured to grasp and hold a catheter 12 (FIGS. 6A-6B) inserted through the skin S of the patient and prevent inadvertent movement of the catheter 12 at a catheter insertion site IS.
  • the illustrated clip 120 includes a body 130 having a pair of opposing elastic jaws 132, 134 that define a catheter receiving channel 130c that extends from a proximal end 130a of the clip body to a distal end 130b of the clip body 130.
  • the catheter receiving channel 130c is configured to accommodate most commercially available sizes (i.e., diameters) of catheters.
  • First and second arms 122, 124 extend outwardly from the clip body 130 in adjacent spaced apart relationship and are configured to be gripped between the fingers of a user, e.g., a healthcare provider, technician, caretaker, etc.
  • the first and second arms 122, 124 when squeezed toward one another by a user, are configured to urge the jaws 132, 134 open such that a catheter 12 (FIG. 6A) can be positioned within the catheter receiving channel 130c.
  • the illustrated base 110 includes first and second legs 142, 144.
  • the first leg 142 extends from a first side of the clip body and the second leg 144 extends from an opposite second side of the clip body, as illustrated.
  • the first and second legs 142, 144 each have an adhesive portion (not shown) on a bottom surface 142a, 144a that is configured to removably secure the secondary catheter securement device 100 to the skin S of the patient.
  • the first and second arms 122, 124 are each movable to a respective nonoperative position such that the device 100 has a reduced profile, as illustrated in FIG. 5B.
  • the first arm 122 and second arm 124 each have a respective hinge (e.g., a living hinge) 122h, 124h that is configured such that the first arm 122 and second arm 124 can be movable to their respective non-operative positions (Fig. 5B).
  • the first arm 122 substantially overlies and aligns with the first leg 142 when the first arm 122 is in its nonoperative position when viewed in plan view (FIG. 6B).
  • the second arm 124 substantially overlies and aligns with the second leg 144 when the second arm 124 in its nonoperative position, when viewed in plan view (FIG. 6B).
  • the first and second arms 122, 124 can be configured in other embodiments not to substantially overlie the first and second legs 142, 144 when the first and second arms 122, 124 are moved to their respective nonoperative positions.
  • an inner wall 130cw of the catheter receiving channel 130c includes one or more features 13 Of that are configured to firmly grip an outer surface of a catheter 12 positioned within the catheter receiving channel 130.
  • These features 130f can prevent forward and backward movement (i.e., pistoning) of the catheter 12 within the catheter receiving channel 130c and at the catheter insertion site IS, especially when the catheter hub 14 is not secured by a primary securement device 20 during dressing change and/or when the catheter hub 14 is being manipulated for site cleaning by a user.
  • an outer surface 122a, 124a of each of the first and second arms 122, 124 includes one or more tactile grip features 126.
  • the grip features 126 help provide better user interaction with the securement device 100, especially in the presence of liquids and other materials that can provide a slippery surface.
  • the secondary catheter securement device 100 is formed from an elastomeric material to facilitate gripping by a user, as well as to facilitate the gripping of an outer surface of a catheter 12 positioned within the catheter receiving channel 130c.
  • the catheter receiving channel 130c may include an elastomeric sleeve to facilitate the gripping of an outer surface of a catheter 12 positioned within the catheter receiving channel 130c.
  • the securement device 100 may be formed from various materials including, but not limited to, all types of plastic materials, ceramic materials, metals, elastomeric materials, or combinations thereof.
  • FIGS. 6A-6B illustrate the catheter securement device 100 in use with a primary catheter securement device 20.
  • FIG. 6A illustrates the catheter securement device 100 with the clip arms 122, 124 in the upright, operative position
  • FIG 6B illustrates the catheter securement device 100 with the clip arms 122, 124 in their respective collapsed position.
  • the secondary catheter securement device 100 is positioned between the catheter insertion site IS and the proximal side of the primary catheter securement device 20.
  • the secondary catheter securement device 100 is secured to the catheter 12 near the catheter insertion site IS after placement of the primary catheter securement device 20 and before dressing.
  • the hemostatic bandage 25a and primary catheter securement device 20 can be removed to allow for 360° site cleaning without increasing risk of catheter movement during catheter manipulation.
  • the secondary catheter securement device 100 allows the catheter to be lifted for site cleaning without risking any movement of the catheter 12 at the insertion site IS.
  • FIGS. 7A-7F schematically illustrate steps for changing the dressing 25 for a catheter using the secondary catheter securement device 100 of FIGS. 5A-5B, according to some embodiments.
  • a hemostatic bandage 25a is placed at the catheter insertion site IS and a transparent adhesive bandage 25b covers the catheter insertion site IS, the hemostatic bandage 25a, the secondary catheter securement device 100 and catheter 12, and the primary catheter securement device 20.
  • the transparent dressing 25b, the primary catheter securement device 20, and the hemostatic bandage 25a are removed, leaving the secondary catheter securement device 100 securing the catheter 12 to the patient (FIG. 7B).
  • the catheter 12 can be lifted, as illustrated in FIG. 7C, and the area around the catheter insertion site IS and where the primary catheter securement device 20 had previously been located can be cleaned, for example with an antiseptic cleaning applicator CA.
  • the catheter 12, catheter hub 14, and catheter extension lines 12e can be cleaned at this time, as well.
  • the catheter hub 14 is attached to a new primary catheter securement device 20, and the primary catheter securement device 20 is secured (e.g., adhesively secured) to the skin of the patient.
  • the arms 122, 124 of the secondary securement device 20 clip are moved to their upright position and a user squeezes the arms 122, 124 together to remove the secondary securement device 100 from the catheter.
  • the site where the secondary catheter securement device 100 was located can be cleaned, including the catheter 12 at the insertion site IS (FIG. 7E).
  • FIG. 7F A new hemostatic bandage 25a is provided at the insertion site IS, and a new secondary catheter securement device 100 is then used to secure the catheter 12 to the skin of the patient between the insertion site IS and the proximal side of the primary catheter securement device 20 (FIG. 7F).
  • the arms 122, 124 of the secondary catheter securement device 100 are moved to their collapsed position to provide a lower profile for the secondary catheter securement device 100, and a transparent bandage 25b can be applied to the patient to cover the insertion site IS and hemostatic bandage 25a, the secondary catheter securement device 100, and the primary catheter securement device 20, as illustrated in FIG. 7A.
  • FIG. 8 illustrates an alternative embodiment for the secondary catheter securement device 100 of FIGS. 5A-5B.
  • the illustrated device 100’ is similar in design and function as the device 100 of FIGS 5A-5B; however, the legs 142, 144 of the base 110 have been modified to allow for less restricted movement of the jaws 132, 134. Specifically, the legs 142, 144 extend further out from the clip body 130 than in the embodiment illustrated in FIGS. 5A- 5B. This allows the adhesive portion of each leg 142, 144 to be positioned further away from the clip body 130, which allows for less restriction of movement of the jaws 132, 134. In addition, the arms 122, 124 of the device 100’ are longer than the arms 122, 124 of the device 100 illustrated n FIGS.
  • the secondary catheter securement device 100’ is formed from an elastomeric material to facilitate gripping by a user, as well as to facilitate the gripping of an outer surface of a catheter 12 positioned within the catheter receiving channel 130c.
  • the catheter receiving channel 130c may include an elastomeric sleeve to facilitate the gripping of an outer surface of a catheter 12 positioned within the catheter receiving channel 130c.
  • the secondary catheter securement device 200 includes an adhesive base 210 (FIG. 10D) configured to be removably secured to the skin S of a patient, and a clip 220 coupled to the base 210.
  • the clip 220 is configured to grasp and hold a catheter that has been inserted into the patient and prevent inadvertent movement of the catheter at the catheter insertion site.
  • FIGS. 12A-12D schematically illustrate steps for changing the dressing for a catheter 12 using the catheter securement device 200 of FIGS. 10A-10D and 11, according to some embodiments.
  • the dressing includes a first dressing 25a that is a hemostatic bandage that is placed at the catheter insertion site IS and a second dressing 25b which is a transparent adhesive bandage that covers the catheter insertion site IS, the hemostatic bandage 25a, and the primary catheter securement device 20 supporting the catheter 12 and hub 14.
  • the hemostatic bandage 25a and the transparent dressing 25b are removed (FIG. 12B).
  • the first collapsible member 440i is secured to the base first end portion 410a and the catheter hub supporting member first end portion 420a
  • the second collapsible member 4402 is secured to the base second end portion 410b and the catheter hub supporting member second end portion 420b.
  • the illustrated first and second collapsible members 4401 and 4402 are accordion-style collapsible members. However, various other types of collapsible structures may be utilized.
  • FIGS. 15A-15G schematically illustrate steps for changing the dressing for a catheter 12 using the secondary catheter securement device 300 and primary catheter securement device 400 of FIGS. 13 and 14A-14B, according to some embodiments.
  • the dressing includes a first dressing 25a that is a hemostatic bandage that is placed at the catheter insertion site IS and a second dressing 25b which is a transparent adhesive bandage that covers the catheter insertion site IS, the hemostatic bandage 25a, the primary catheter securement device 400, and the catheter 12 and hub 14 supported by the primary catheter securement device 400.
  • the catheter hub supporting member 420 can be raised, thereby elevating the catheter 12 and hub 14 to permit cleaning therebeneath.
  • the catheter hub supporting member 420 is then lowered, a new hemostatic bandage 25a can be applied to the insertion site IS, and a new transparent adhesive bandage 25b can be applied to the patient to cover the insertion site IS and hemostatic bandage 25a, and the primary catheter securement device 400 (FIG. 15G).
  • FIG. 16 illustrates the secondary catheter securement device 300 of FIGS. 14A- 14B in use with the primary catheter hub securement device 20 of FIG. 6A.
  • FIG. 17 illustrates a secondary catheter securement device 500 in use with the primary catheter securement device 400 of FIG.13, according to some embodiments of the present inventive concept.
  • the illustrated secondary catheter securement device 500 combines a hemostatic bandage 25a that is configured to be positioned at a catheter insertion site of a patient with the secondary catheter securement device 300 of FIGS. 14Aand 14B.
  • the hemostatic bandage 25a and the elongate base 310 of the secondary catheter securement device 300 are joined together in adjacent, spaced apart relationship by a pair of members 510.
  • each member 510 is joined to a respective end portion 310a, 310b of the elongate member 310.
  • Each member 510 is tearable such that the hemostatic bandage 25a can be removed from the patient without removing the elongate base 310, which is securing the catheter 12 to the patient.
  • FIGS. 18A-18C illustrate a secondary catheter securement device 600 according to some embodiments of the present inventive concept.
  • the secondary catheter securement device 600 includes a base 610 configured to be removably secured to the skin S of a patient, and a catheter supporting member 620 movably coupled to the base 610.
  • the catheter supporting member 620 includes one or more catheter receiving channels 630c, each configured to snugly hold a catheter or catheter extension line and prevent inadvertent movement of the catheter/ catheter extension line.
  • a clamp member 632 is movably secured to the catheter supporting member 620 via a hinge 634 and is configured to move between open and closed positions.
  • the clamp member 632 is configured to firmly retain the catheters/catheter extension lines that are placed within the catheter receiving channels 630c and prevent any inadvertent movement thereof.
  • the clamp member 632 in an open position (FIG. 19E), one or more catheters/catheter extension lines can be placed within one or more of the catheter receiving channels 630c.
  • the clamp member 632 can then be moved to the closed position (FIG. 19F) overlying the catheters/catheter extension lines, thereby securing the catheters/catheter extension lines within the catheter receiving channels 630c.
  • the catheter supporting member 620 is movable relative to the base 610 via a hinge member 640 between a first (i.e., collapsed) position (FIG. 18A) and a second (i.e., raised) position (FIG. 18B).
  • the catheter supporting member 620 is in face-to-face contacting relationship with the base 610 when in the lowered position, as illustrated in FIG. 18 A.
  • the catheter supporting member 620 is in spaced apart relationship with the base 610 when in the second, raised position, as illustrated in FIG. 18B.
  • the illustrated catheter securement device 600 also includes first and second locking members 652, 654 that are configured to removably secure the catheter supporting member 620 to the base 610 when in the second, raised position.
  • a first locking member 652 is movably secured to a first end portion 620a of the catheter supporting member 620 via a hinge member 660a
  • a second locking member 654 is movably secured to an opposite second end portion 620b of the catheter supporting member 620 via a hinge member 660b.
  • each locking member 652, 654 includes a tab (not shown) that is configured to be releasably secured within a recessed portion 670 of the base 610 to maintain the catheter supporting member 620 in the raised position (FIG. 18C).
  • a tab not shown
  • FIG. 18C the raised position
  • other ways of removably securing each locking member 652, 654 to the base 610 may be utilized, and embodiments of the present inventive concept are not limited to the illustrated configuration.
  • more than two locking members may be utilized, and even a single locking member may be utilized.
  • the base 610 and catheter supporting member 620 may be formed from polymeric materials.
  • the securement device 600 may be formed from various materials including, but not limited to, all types of plastic materials, ceramic materials, metals, elastomeric materials, or combinations thereof.
  • FIGS. 19A-19M schematically illustrate steps for changing the dressing for a catheter 12 using the catheter securement device 600 of FIGS. 18A-18C, according to some embodiments.
  • the dressing includes a first dressing 25a that is a hemostatic bandage that is placed at the catheter insertion site IS and a second dressing 25b which is a transparent adhesive bandage that covers the catheter insertion site IS, the hemostatic bandage 25a, the primary catheter securement device 20, and the catheter 12 and hub 14 supported by the primary catheter securement device 20.
  • the transparent adhesive bandage 25b is removed (FIG. 19B) and the hemostatic bandage 25a is removed (FIG. 19C).
  • the area around the catheter insertion site IS can be cleaned, for example with an antiseptic cleaning applicator CA (FIG. 191).
  • the secondary catheter securement device 600 is then moved beneath the catheter extension lines 12e on the distal side of the primary catheter securement device 20 (FIG. 19D), the clamp member 632 is opened (FIG. 19E), and the catheter extension lines 12e are placed within the catheter receiving channels 630c and the clamp member 632 is closed, thereby firmly securing the catheter extension lines 12e to the catheter supporting member 620 (FIGS. 19E- 19F).
  • This operation avoids the need for the person installing the secondary catheter securement device 600 to touch the catheter 12 at or near the insertion site IS.
  • the catheter supporting member 620 is moved to the raised position via hinge 640 and the locking members 652, 654 are pivoted downwardly and secured to the base 610 (FIGS. 19G-19H).
  • the catheter supporting member 620 is now securely raised above the base 610.
  • the primary catheter securement device 20 is then removed (FIG. 19H) and site cleaning can be performed near the insertion site IS and beneath the catheter 12, hub 14, and catheter extension lines 12e (FIG. 191).
  • the locking member 654 is shown in the raised position to better illustrate the hinge 640. However, it is understood that the locking member 654, as well as the locking member 652, would be in the downward position during site cleaning.
  • a new primary catheter securement device 20 is secured to the patient and the catheter hub 14 is secured within the primary catheter securement device 20 (FIG.19J).
  • the locking members 652, 654 are released from the base 610, pivoted upwardly, and the catheter supporting member 620 is moved to the lowered position (FIG. 19K).
  • the catheter extension lines are released from the catheter receiving channels 630c and the secondary catheter securement device 600 is removed from beneath the catheter extension lines and from the patient (FIG. 19L). Cleaning may be performed at the site near where the secondary catheter securement device 600 was positioned (FIG. 19L).
  • a new hemostatic bandage 25a can be applied to the insertion site IS, and a new transparent adhesive bandage 25b can be applied to the patient to cover the insertion site IS and hemostatic bandage 25a, and the primary catheter securement device 20 (FIG. 19M).
  • FIGS. 20A-20C illustrate a secondary catheter securement device 700 according to some embodiments of the present inventive concept.
  • the secondary catheter securement device 700 includes a base 710 configured to be removably secured to the skin S of a patient, and a catheter supporting member 720 overlying the base 710 and movably secured to the base 710 between a lowered position (FIG. 20A) and a raised position (FIG. 20B).
  • the base 710 and the catheter supporting member 720 are in close, adjacent relationship when the catheter supporting member 720 is in the lowered position, as illustrated in FIG. 20A, and the base 710 and the catheter supporting member 720 are in extended, spaced apart relationship when the catheter supporting member 720 is in the raised position, as illustrated in FIG. 20B.
  • the catheter supporting member 720 includes a holder 730 that is configured to snugly hold one or more catheters or catheter extension lines (FIG. 20C) therein and prevent inadvertent movement thereof.
  • the illustrated holder 730 has a generally U-shaped configuration with opposing arms 732, 734.
  • the arms 732, 734 are configured to bias inwardly toward each other which helps firmly retain any catheters/catheter extension lines inserted therein.
  • the catheter supporting member 720 is movably secured to the base 710 by at least one collapsible member.
  • a pair of collapsible members 7401, 7402 are provided.
  • the base 710 includes opposite first and second end portions 710a, 710b, and the catheter hub supporting member 720 includes opposite first and second end portions 720a, 720b.
  • the first collapsible member 7401 is secured to the base first end portion 710a and the catheter hub supporting member first end portion 720a.
  • the second collapsible member 7402 is secured to the base second end portion 710b and the catheter hub supporting member second end portion 720b.
  • the illustrated first and second collapsible members 740i and 7402 are accordionstyle collapsible members. However, various other types of collapsible structures may be utilized.
  • the secondary catheter securement device 700 may be formed from polymeric materials.
  • the securement device 700 may be formed from various materials including, but not limited to, all types of plastic materials, ceramic materials, metals, elastomeric materials, or combinations thereof.
  • FIGS. 21A-21G schematically illustrate steps for changing the dressing for a catheter 12 using the catheter securement device 700 of FIGS. 20A-20C, according to some embodiments.
  • the dressing includes a first dressing 25a that is a hemostatic bandage that is placed at the catheter insertion site IS and a second dressing 25b which is a transparent adhesive bandage that covers the catheter insertion site IS, the hemostatic bandage 25a, the primary catheter securement device 20, and the catheter 12 and hub 14 supported by the primary catheter securement device 20.
  • the transparent adhesive bandage 25b and the hemostatic bandage 25a are removed (FIG. 2 IB).
  • the area around the catheter insertion site IS can be cleaned, for example with an antiseptic cleaning applicator CA (FIG. 2 ID).
  • the secondary catheter securement device 700 is then moved beneath the catheter extension lines 12e on the distal side of the primary catheter securement device 20, and the catheter extension lines 12e are placed within the holder 730 (FIG. 21C). Once the catheter extension lines 12e are within the holder 730, the primary catheter securement device 20 can be removed. The catheter supporting member 720 is then moved to the raised position and site cleaning can be performed where the primary catheter securement device 20 was located, as well as beneath the catheter 12 and the catheter extension lines 12e (FIG. 21D).
  • a new primary catheter securement device 20 is secured to the patient and the catheter hub 14 is secured within the primary catheter securement device 20 (FIG. 2 IE). Cleaning may be performed at the site near where the secondary catheter securement device 700 was positioned (FIG. 21F). Finally, a new hemostatic bandage 25a can be applied to the insertion site IS, and a new transparent adhesive bandage 25b can be applied to the patient to cover the insertion site IS and hemostatic bandage 25a, and the primary catheter securement device 20 (FIG. 21G). [0088] It will be understood that, although the terms first, second, etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another.
  • first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of the present invention.
  • second element could be termed a first element, without departing from the scope of the present invention.
  • the term “and/or” includes any and all combinations of one or more of the associated listed items.
  • Relative terms such as “below” or “above” or “upper” or “lower” or “horizontal” or “vertical” may be used herein to describe a relationship of one element, layer or region to another element, layer or region as illustrated in the figures. It will be understood that these terms are intended to encompass different orientations of the device in addition to the orientation depicted in the figures.
  • a measurable value such as an amount or concentration and the like, is meant to encompass variations of ⁇ 10%, ⁇ 5%, ⁇ 1%, ⁇ 0.5%, or even ⁇ 0.1% of the specified value as well as the specified value.
  • “about X” where X is the measurable value is meant to include X as well as variations of ⁇ 10%, ⁇ 5%, ⁇ 1%, ⁇ 0.5%, or even ⁇ 0.1% of X.
  • a range provided herein for a measurable value may include any other range and/or individual value therein.

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  • Pulmonology (AREA)
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  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
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Abstract

Un dispositif de sécurisation de cathéter secondaire (100) est conçu pour maintenir un cathéter ou une ligne d'extension de cathéter de manière adjacente à un dispositif de fixation de cathéter primaire, de sorte qu'un dispositif de fixation de cathéter primaire peut être retiré et remplacé et un nettoyage de site peut être mis en oeuvre pendant un changement de pansement sans augmenter le risque de déplacement de cathéter. Le dispositif de fixation de cathéter (100) comprend une base (110) conçue pour être fixée de manière amovible à la peau d'un patient; et une pince (120) couplée à la base (110), la pince (120) étant conçue pour saisir et retenir un cathéter inséré chez le patient et empêcher un déplacement accidentel du cathéter au niveau d'un site d'insertion de cathéter.
PCT/US2024/042208 2023-09-12 2024-08-14 Dispositifs de fixation de cathéter WO2025058775A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN202341061291 2023-09-12
IN202341061291 2023-09-12
IN202441028019 2024-04-04
IN202441028019 2024-04-04

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5681290A (en) * 1994-07-28 1997-10-28 Medisys Technologies, Inc. Apparatus and method for preventing tug trauma to intravenous or intracavity insertion sites
US6428515B1 (en) * 2000-06-01 2002-08-06 Venetec International, Inc. Anchoring system for leur lock connector
WO2011133818A1 (fr) * 2010-04-22 2011-10-27 Venetec International, Inc. Système de fixation d'articles médicaux
KR20180052327A (ko) * 2016-11-10 2018-05-18 주식회사 새움메디텍 의료용 튜브 고정 클립
CN110339458A (zh) * 2019-07-10 2019-10-18 毕成龙 一种心内科临床介入治疗导管固定装置
US10537714B2 (en) * 2009-11-11 2020-01-21 Venetec International, Inc. Stabilizing device for an extension set
US20200330733A1 (en) * 2019-04-17 2020-10-22 Bard Access Systems, Inc. Catheter Securement Device Including Extended Anchor Pad and Release Liner Clasping Features
US20210023342A1 (en) * 2018-04-11 2021-01-28 Livanova Usa, Inc. Cannula fixation device
CN114949547A (zh) * 2022-07-05 2022-08-30 河北医科大学第二医院 一种腺体外科护理用的引流管固定装置

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5681290A (en) * 1994-07-28 1997-10-28 Medisys Technologies, Inc. Apparatus and method for preventing tug trauma to intravenous or intracavity insertion sites
US6428515B1 (en) * 2000-06-01 2002-08-06 Venetec International, Inc. Anchoring system for leur lock connector
US10537714B2 (en) * 2009-11-11 2020-01-21 Venetec International, Inc. Stabilizing device for an extension set
WO2011133818A1 (fr) * 2010-04-22 2011-10-27 Venetec International, Inc. Système de fixation d'articles médicaux
KR20180052327A (ko) * 2016-11-10 2018-05-18 주식회사 새움메디텍 의료용 튜브 고정 클립
US20210023342A1 (en) * 2018-04-11 2021-01-28 Livanova Usa, Inc. Cannula fixation device
US20200330733A1 (en) * 2019-04-17 2020-10-22 Bard Access Systems, Inc. Catheter Securement Device Including Extended Anchor Pad and Release Liner Clasping Features
CN110339458A (zh) * 2019-07-10 2019-10-18 毕成龙 一种心内科临床介入治疗导管固定装置
CN114949547A (zh) * 2022-07-05 2022-08-30 河北医科大学第二医院 一种腺体外科护理用的引流管固定装置

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