WO2020182686A1 - Dispositif de fixation pour un tube intravasculaire - Google Patents

Dispositif de fixation pour un tube intravasculaire Download PDF

Info

Publication number
WO2020182686A1
WO2020182686A1 PCT/EP2020/056099 EP2020056099W WO2020182686A1 WO 2020182686 A1 WO2020182686 A1 WO 2020182686A1 EP 2020056099 W EP2020056099 W EP 2020056099W WO 2020182686 A1 WO2020182686 A1 WO 2020182686A1
Authority
WO
WIPO (PCT)
Prior art keywords
elongated member
fixation
dressing
limb
tube
Prior art date
Application number
PCT/EP2020/056099
Other languages
English (en)
Other versions
WO2020182686A9 (fr
Inventor
Nils Petter OVELAND
Original Assignee
Dr. No Invest As
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 Dr. No Invest As filed Critical Dr. No Invest As
Publication of WO2020182686A1 publication Critical patent/WO2020182686A1/fr
Publication of WO2020182686A9 publication Critical patent/WO2020182686A9/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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • 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
    • A61M2025/0213—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human 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
    • A61M2025/0246—Holding devices, e.g. on the body fixed on the skin having a cover for covering the holding means
    • 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
    • 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

Definitions

  • the present disclosure relates to a fixation device structured to fixate and secure an intravascular (IV) tube, and a medical kit comprising such a fixation device.
  • IV intravascular
  • peripheral venous catheter In medicine, terms such as peripheral venous catheter, peripheral venous line, peripheral intravenous line, peripheral venous access catheter, peripheral arterial catheter, peripheral arterial line, peripheral intra-arterial line, peripheral arterial access catheter, cannula and more are used for describing a small, flexible tube, which is configured to be introduced intravascularly into a peripheral vein or artery of a human or animal patient in order to administer medication or fluids, measure intravascular blood pressure or draw blood for testing.
  • IV intravascular
  • veins and arteries may be collectively referred to as blood vessels.
  • the IV tube can also be used to draw blood.
  • An IV tube is typically placed in a vein or artery on the hand, arm, or other suitable limb of the human or animal patient.
  • the IV tube is introduced into the vein or artery by a needle (similar to blood drawing), which is subsequently removed while the small flexible tube of the IV tube remains in place.
  • the IV tube is then fixed by taping it to the patient's skin (unless there is allergy to adhesives).
  • Newer IV tubes have been equipped with additional safety features to avoid needle-stick injuries.
  • the IV tube is the most commonly used vascular access in medicine. It is given to most critical ill and surgical patients, and before some radiological imaging techniques using radio contrast, for example.
  • Insertion of an IV tube is a painful procedure that can lead to anxiety and stress. Infection, phlebitis, extravasation, infiltration, air embolism, haemorrhage (bleeding) and formation of a hematoma (bruise) may also occur.
  • Embodiments of the present disclosure aim at solving or at least ameliorating the identified problems.
  • a fixation device for fixating and securing an intravascular, IV, tube
  • the fixation device comprising: a flexible elongated member, comprising a first portion and a second portion configured to be attachable to each other, wherein the elongated member is configured to be attached, and possibly also tightened, around a limb of a human or animal patient at a first location, via said first and second portions; a fixation dressing, comprising at least one adhesive layer configured to be attachable to the skin of the patient, wherein the fixation dressing is detachably attached to the elongated member at a third portion of the elongated member.
  • the elongated member is further configured to be tightened around the limb to provide vascular stasis in the limb, thereby enabling easier introduction of an IV tube.
  • the fixation dressing further comprises an absorbent layer.
  • the fixation dressing further comprises a top protective layer.
  • the fixation dressing further comprises a bottom protective layer.
  • the detachable attachment between the elongated member and fixation dressing may be achieved by means of at least one of: perforation, indentions, punching, stitching, welding, Velcro® and adhesive.
  • the detachable attachment between the elongated member and fixation dressing comprises the fixation dressing being detachably attached to the elongated member along a longitudinal side of the third portion.
  • the elongated member has a first, non-cutaneous, surface facing away from the skin of the patient when the elongated member is attached to the limb; and an opposing second, cutaneous, surface, facing towards the skin of the patient when the elongated member is attached to the limb; wherein the fixation dressing has a first, non- cutaneous, surface facing away from the skin of the patient when the elongated member is attached to the limb; and an opposing second, cutaneous, surface facing towards the skin of the patient when the elongated member is attached to the limb.
  • the detachable attachment may comprise the first, non-cutaneous, surface of the fixation dressing being detachably attached to the second, cutaneous, surface of the third portion of the elongated member.
  • the detachable attachment may comprise the second, cutaneous, surface of the fixation dressing being detachably attached to the first, non- cutaneous, surface of the third portion of the elongated member.
  • the fixation dressing is foldable in relation to the elongated member along an axis parallel to, or substantially parallel to, the longitudinal side of the third portion.
  • the elongated member is further configured to, after detachment from the fixation dressing, be attached around the limb of the human or animal patient at a second location, to provide further fixation and securement of the IV tube.
  • the elongated member may in these embodiments be configured to be attached around the limb (500), at the second location, via said first and second portions.
  • the elongated member may in these embodiments have a first, non- cutaneous, surface and a second, cutaneous, surface, and further comprise an adhesive layer on at least one of said first, non-cutaneous, surface and said second, cutaneous, surface.
  • the adhesive layer may be configured to be attachable to the skin of the human or animal patient and/or to the first, non-cutaneous, surface of the fixation dressing, for example crossing the fixation dressing underneath or over the IV tube, wherein the elongated member may be configured to be attached around the limb, at the second location, via the adhesive layer.
  • the elongated member is made from at least one of, but not limited to, the following materials: Tyvek® paper, other non-rip paper, non-rip polymer material, fabric, Velcro® and a suitable plastic material.
  • a medical kit comprising a kit package configured to enclose a fixation device according to any of the embodiments presented herein, and at least one of: one or more disinfection wipes for washing the skin of a patient; an IV tube to insert into a vein or artery; and a syringe prefilled with a saline solution.
  • Figure 1A shows a fixation device according to one or more embodiments
  • Figure 1 B shows a fixation device according to one or more embodiments
  • Figure 2A to 2D respectively, show a schematic overview of detachable attachment alternatives according to different embodiments
  • Figure 3A to 3H show the layered structure of fixation dressing alternatives according to different embodiments
  • Figure 4 illustrates as example of a standard IV tube
  • Figures 5A and 5B illustrate a previous solution for an IV tube procedure
  • FIGS 6A to 6D illustrate an IV tube procedure according to one or more embodiments
  • Figure 7 shows a schematic overview of a medical kit according to one or more embodiments
  • Figures 8A and 8B show exemplary embodiments of connection of a first and second portion of the elongated member
  • An IV tube in the context of this disclosure may include any known type of IV catheter, IV line, peripheral venous catheter, peripheral venous line, peripheral intravenous line, peripheral venous access catheter, peripheral arterial catheter, peripheral arterial line, peripheral intra-arterial line, peripheral arterial access catheter, cannula, needle, IV tube, guidewire, introducer, or other small, flexible tube that is configured to be introduced into a vein or artery of a human or animal patient.
  • Figure 4 illustrates an example of a standard IV tube, 400, wherein the IV tube itself is composed of a tip 401 for insertion into a blood vessel, i.e. a vein or an artery, wings 402 for manual handling and securing the IV tube with adhesives, a valve 403 to allow injection of drugs with a syringe, and an end 404 which allows connection to an IV infusion line, and capping in between uses.
  • a needle 410 (partially retracted in the figure) which serves to puncture the skin and further and thereafter as a guide-wire for inserting the IV tube into the blood vessel, and a protection cap 420, which normally covers the needle's tip when the needle is not in use.
  • the steps of attaching a fixation device to a limb of a human or animal patient, optionally providing stasis in the limb to make identification of a blood vessel and thereby introduction of an IV tube easier for the health care personnel, and further fixation of the IV tube after it has been inserted, may hereinafter be referred to as an IV tube procedure. If the IV tube is to be introduced into a vein, it is evident that stasis facilitates this introduction, as stasis compresses the veins of the limb so that they fill up with blood whereby the diameter of the vessel lumen is increase and the veins are easier to identify, manually or using visualization.
  • stasis may be advantageous also in this case, since ultrasound identification of arteries can be made easier if there is a light stasis of the limb, since a light pressure against an artery makes it pulsate more and therefore makes it easier to identify, using manual palpation or ultrasound visualization.
  • Figure 5A illustrates how an elongated member 501 , for example in the form of an elastic belt, is attached around a patient’s limb 500, in this case an arm.
  • the elastic belt may be tightened around the limb 500 to obtain vascular stasis, which may be light or strong depending on which type of blood vessel the IV tube is intended to be introduced into.
  • the elastic belt 501 is typically used on multiple consecutive patients, not uncommonly without being washed or disinfected in-between patients. This may cause hygienic problems such as spreading of infections etc. between patients and possibly also to the health care personnel.
  • the insertion site is washed with a disinfective solution; where after an IV tube 400 is inserted, possibly using a needle 410 to puncture the skin and thereafter as a guide-wire to slide or introduce the IV tube 400 into the blood vessel.
  • the IV tube 400 has been inserted into a blood vessel of the patient, by a health care personnel, the needle 410, if used, is retracted, and the IV tube 400 is taped to the patient ' s skin using an adhesive bandage 502.
  • the adhesive bandage 502 is typically placed such that it covers the wings 402 of the IV tube 400.
  • an IV infusion line 504 also referred to as an IV line 504 may be connected to the end 404 of the IV tube 400.
  • fixation dressings used to fixate and secure IV tubes
  • fixation dressings used to fixate and secure IV tubes
  • a pull of the IV infusion line could easily pull the IV tube out of the blood vessel. This is an unnecessary, but far too common, complication, especially in emergency situations. If the IV tube is pulled out of the blood vessel, the health care personnel will lose the opportunity to administer drugs and fluid, and will often have to repeat the IV tube procedure, which takes additional time in a sometimes already time critical situation, keeps the health care personnel from performing other tasks, and increases the discomfort of the currently treated patient, including pain from multiple punctures to the skin.
  • Embodiments of the present device presented herein solve these and other problems.
  • FIGS 1A and 1 B embodiments of a fixation device 100 for fixating and securing an intravascular, IV, tube are shown.
  • the fixation device 100 comprises a flexible elongated member 110 and a fixation dressing 120, wherein the fixation dressing 120 is detachably attached to the elongated member 110, at a third portion 116 of the elongated member 110.
  • the elongated member comprises a first portion 112 and a second portion 114 configured to be attachable to each other.
  • detachably attached is to be understood as the attached elongated member 110 and fixation dressing 120 being detachable from each other by hand force.
  • the fixation device 100 is configured such that a healthcare provider that inserts IV tubes as part of their work, for instance a physician, a nurse, a medical student, an emergency medical service worker, a veterinarian etc., can pull apart, or in other ways separate from each other, the flexible elongated member 110 and the fixation dressing by hand force.
  • a healthcare provider that inserts IV tubes as part of their work, for instance a physician, a nurse, a medical student, an emergency medical service worker, a veterinarian etc.
  • there is no need for any additional tool for example, scissors are not required.
  • the first and second portions 112, 114 may further be configured to, after attachment, further be detachable from and re-attachable to each other. Thereby, attachment of the elongated member 110, as described in connection with Figure 6D, may further be enabled.
  • the elongated member 110 may be configured to be attached, and possibly also tightened, around a limb 500 of a human or animal patient, at a first location, via said first and second portions 112, 114.
  • the attachment and possibly also tightening of the elongated member 110 provides vascular, i.e. venous or arterial, stasis in the limb 500.
  • vascular i.e. venous or arterial
  • stasis in the limb 500.
  • the health care personnel are enabled to easier identify a blood vessel for penetration with the IV tube, using manual palpation or ultrasound/ultrasonic visualization for arteries, or eye sight, visualization or ultrasound/ultrasonic visualization for veins.
  • fixation device 100 may assist the health care personnel in aligning the IV tube 400 against the limb 500, and that the fixation dressing 120 is close at hand after the IV tube has been introduced into the blood vessel, as further described herein.
  • the fixation dressing 120 comprises a layered structure, wherein the fixation dressing 120 comprises at least an adhesive layer 122 configured to be attachable to the skin of the patient.
  • the fixation dressing 120 may comprise one or several further layers, such as an absorbent layer, a top protective layer, and/or a bottom protective layer. These alternative embodiments are further described in connection with figures 3A to 3H.
  • the fixation dressing may be partly or fully transparent to visualize the underlying insertion point of the IV tube and/or skin of the human or animal patient. This can make it easier for the health care personnel to identify bleeding and infection around the puncture site or even identify kinking of the IV tube, dislodgement or extravasation.
  • the elongated member 110 may in the context of this disclosure include any known type of band etc. that is configured to be attached around a limb 500 of a human or animal patient, to provide vascular stasis in said limb.
  • the elongated member 110 may be made of any material, or selection of materials, that have the properties of being flexible enough to be wrapped around a limb 500, strong enough not to rip or tear when a longitudinal force is applied on it upon tightening around a limb 500 to obtain vascular stasis, and preferably also cheap to produce.
  • Non-limiting examples of materials that can be used are strong types of paper, as a specific non-limiting example the paper can be Tyvek® paper, a non-rip polymer material or a suitable plastic material.
  • the elongated member 110 may at least partly be elastic in a longitudinal direction. As an alternative, the elongated member 110 may be non elastic in a longitudinal direction.
  • the fixation device 100 may advantageously be sterile and/or for single use.
  • Single use in this context means that the fixation device 100 is used on a single patient during one IV tube procedure, wherein the IV tube procedure is defined as attaching the elongated member 110 to the limb 500, and optionally providing stasis, before introduction of an IV tube, and fixating and securing the IV tube to the patient after it has been introduced.
  • both the elongated member 110 and the fixation dressing 120 may be disposed of, once they have fulfilled their respective purpose. In the case of the fixation dressing 120, this may be disposed of after the IV tube has been removed from the limb of the human or animal patient.
  • the elongated member 110 is sterile and/or single use and can be disposed after having been attached around a limb of the human or animal patient at a first location, and optionally also at a second location, as described in connection with Figure 6D, this is clearly more hygienic than an elastic belt or other alternatives that are used on multiple patients before being washed, if ever. If the health care center has a system for washing these elastic belts or other alternatives, the washing procedure further takes time and costs money.
  • the fixation device 100 according to the embodiments presented herein is therefore more hygienic and time-efficient than previous solutions.
  • the limb 500 is illustrated as an arm of a human.
  • the embodiments presented herein are not limited for use on humans, but may also advantageously be used on animal patients.
  • the embodiments presented herein are further not limited for use on a specific limb, but may be used on any suitable limb or body part where introduction of an IV tube is desired.
  • Some non-limiting examples of such limbs are a wrist, an underarm, an upper arm, a thigh, a foot and a leg.
  • the elongated member 110 is made to a sufficient length to wrap around a type of limb to which the IV fixation device 100 is intended to be attached. In one or more embodiments, the elongated member 110 is made to a sufficient length to wrap around a type of limb to which the IV fixation device 100 is intended to be attached and to permit an area of overlap at the ends thereof. For example, if the first and second portions 112, 114 are located at a respective end of the elongated member 110, there may be permitted an overlap of at least part of the first and second portions 112, 114.
  • one of the first and second portions 112, 114 may comprise a fastening element (not shown in the figures) adapted to connect or attach to the other of the first and second portions 112, 114, thus providing easy attachment around the patient’s limb 500.
  • the fastening element may further be adapted to disconnect or detach after attachment, and optionally also be adapted to reconnect or reattach to the other of the first and second portions 112, 114.
  • each of the first and second portions 112, 114 may comprise or form a respective part of a fastening element (not shown in the figures) adapted to connect or attach to each other, thus providing easy attachment around the patient’s limb 500 in an alternative manner.
  • the parts of the fastening element may also in this case further be adapted to disconnect or detach from each other after attachment, and optionally also be adapted to reconnect or reattach to each other.
  • a fastening element, in one or two parts may comprise a variety of different configurations and manners of attachment, including, but not limited to, Velcro®, snaps, hooks, bikini- clasps, clips, buttons, adhesive applied to one or both of the first and second portions 112, 114, etc.
  • a fastening element, in one or two parts may in other embodiments comprise a variety of different configurations and manners of connecting the first and second portions 112, 114, including, but not limited to a strap buckle, clasp or similar structure.
  • Figure 8B Such embodiments are schematically illustrated in Figure 8B.
  • the fastening element is preferably adapted such that it is quick and easy to attach, and likewise easy to detach, while still providing optimal secure attachment. This is especially important when using the fixation arrangement in medical emergency and trauma settings, or when the patient shows signs of anxiety.
  • the secure attachment may be enabled by the fastening member locking the elongated member 110 in the desired tightened position. If there is no locking mechanism, the same result may be achieved by the first portion 112 further being configured to be fixedly attached or connected to a fourth portion 812, by means of an adhesive or any of the other manners of attachment described in connection with Figure 8A.
  • a strap buckle, clasp or similar structure may be used for locking the elongated member 110 at a desired length around the limb 500 by means of a locking mechanism, or the further attachment of the first portion 112 to the fourth portion 812.
  • the connection or attachment of the first portion 112 to the second portion 114 can be reversed, i.e. the first and second portions 112, 114 can be detached again from each other
  • the connection or attachment of the first portion 112 to the fourth portion 812 can also be reversed, i.e. the first and fourth portions 112, 812 can be detached again from each other.
  • An advantage with the embodiments of the fastening member of Figure 8B is that a great variation of the resulting length of the elongated member after attachment to the limb 500 is enabled. Therefore, the fixation device 100 according to embodiments presented herein work well for limbs of different diameter, as the elongated member 110 can have the necessary length to fit around any sized limb 500.
  • the size of the elongated member 110 i.e. the length/longitudinal extension and/or the width of the elongated member 110, may further be adapted to fit/wrap around a type of limb to which the IV fixation device 100 is intended to be attached.
  • a border 118 also referred to as a longitudinal side 118, along the third portion 116, marks the location where the fixation dressing 120 is detachably attached to the elongated member 110.
  • the detachable attachment comprises the fixation dressing 120 being detachably attached to the elongated member 110 along a longitudinal side 118 of the third portion 116.
  • Figure 2A shows a side view of the third portion 116 of the elongated member 110, the fixation dressing 120, and the border 118 at which the third portion 116 and the fixation dressing 120 are detachably attached, and thereby being configured to allow a user to apply hand force to break, rip, pull or tear the fixation dressing 120 from the elongated member 110 via the border or longitudinal side 118.
  • Figure 2C is very similar to Figure 2A, but further includes an element 130, between the third portion 116 and the fixation dressing 120, which may in some embodiments represent an adhesive, stitching, punching, Velcro®, welding, i.e. textile welding, ultrasonic welding or electro welding or similar, or other attachment means detachably attaching the third portion 116 of the elongated element 110 to the fixation dressing 120, and being configured to allow a user to apply hand force to break, rip, pull or tear the fixation dressing 120 from the elongated member 110 via the border or longitudinal side 118.
  • Figure 1 B there is illustrated an alternative embodiment for the fixation dressing 120 being detachably attached to the elongated member 110.
  • the third portion 116 of the elongated member 110 overlaps with the fixation dressing 120, and the detachable attachment is provided in the overlapping area.
  • Figure 2B shows a side view of the third portion 116 of the elongated member 110 and the fixation dressing 120 overlapping.
  • the third portion 116 of the elongated member 110 has a first, non-cutaneous, surface 113 and a second, cutaneous, surface 115.
  • the fixation dressing 120 has a first, non- cutaneous, surface 117 and a second, cutaneous, surface 119.
  • the detachable attachment may comprises the second, cutaneous, surface 115 of the third portion 116 of the elongated member 110 being detachably attached to the entire, or part of the, first, non-cutaneous, surface 117 of the fixation dressing 120. This is illustrated in Figure 2B.
  • the elongated member 110 and the fixation dressing 120 may instead be combined in the opposite order, with the fixation dressing 120 above or over the elongated member 110, or in other words farther away from the limb 500 than the elongated member 110.
  • the detachable attachment may comprise the second, cutaneous, surface 119 of the fixation dressing 120 being detachably attached to the entire, or part of the, first, non-cutaneous, surface 113 of the third portion 118 of the elongated member 110, thereby being configured to allow a user to apply hand force to break rip, pull or tear the fixation dressing 120 from the elongated member 110 via the third portion 116.
  • Figure 2D is very similar to Figure 2B, but further includes an element 130, between the third portion 116 of the elongated element 110 and the fixation dressing 120 (which may be combined in any order, as described herein).
  • the element 130 may in some embodiments represent an adhesive, stitching, perforation, indentions, punching, Velcro®, welding, i.e. textile welding, ultrasonic welding or electro welding or similar, or other attachment means configured to detachably attaching the third portion 116 of the elongated element 110 to the fixation dressing 120, and further being configured to allow a user to apply hand force to break rip, pull or tear the fixation dressing 120 from the elongated member 110 via the third portion 116.
  • the attachment means may be applied over all or part of the overlapping area.
  • the fixation dressing 120 extends on both sides of the elongated member 110, as indicated by the dotted part of the fixation dressing 120, extending on the other side of the elongated member 110 as seen from the main part of the fixation dressing, by a distance D.
  • the fixation dressing 120 may be substantially rectangular in shape, as illustrated in the figures.
  • the fixation dressing 120 is not, however, limited to this shape, but may have any other shape that is suitable for fixating and securing an IV tube when the fixation dressing is applied or attached onto the skin of the human or animal patient.
  • the fixation dressing 120 may have a cutout portion 121 configured to receive an IV tube when the fixation dressing 120 is applied or attached onto the skin of the human or animal patient. The cutout portion 121 will then improve the fixation of the IV tube 400 by enabling the fixation dressing 120 to cover the wings 402 of the IV tube 400.
  • FIG. 3A to 3H show the layered structure of a fixation dressing according to different embodiments.
  • Said layered structure may comprise at least one layer, including the options of comprising one, two, three, four, five or more layers.
  • Figure 3A shows an embodiment wherein the fixation dressing 120 comprises a single adhesive layer 122, comprising any adhesive material structured to attach to the skin of a human or animal, to make the fixation dressing 120 easy to attach and keep attached.
  • the adhesive layer can also contain a tape or another suitable adhesive.
  • the adhesive layer 122 is the layer of the fixation dressing 120 that is arranged closest to the limb 500 to which the fixation dressing 120 is attached. This layer provides for attachment of the device to the skin of the human or animal patient.
  • the adhesive layer 122 may comprise a hydrogel.
  • the hydrogel may advantageously be an adhesive hydrogel.
  • the fixation dressing 120 is also provided with an absorbent layer 126.
  • the absorbent layer may in one or more embodiments be combined with the adhesive layer 122, as shown in Figure 3B.
  • the absorbent layer is preferably adapted to be arranged above or over said adhesive layer 122 in relation to the body of said human or animal patient, i.e. further from the skin of the patient than the adhesive layer 122.
  • the absorbent layer 126 which may in these embodiments be described as the core of the fixation dressing 120, advantageously functions to absorb excess fluids, such as blood, sweat and other bodily fluids, making the fixation dressing 120 easier to secure and keep attached. This advantageous effect enables good fixation even if the patient’s skin is cold or moist.
  • the absorbent layer 126 further provides for the absorption of any body fluids excreted from or present around the entry area of the IV tube 400.
  • the absorbent layer 126 covers at least the same surface area as the adhesive layer 122.
  • the adhesive layer 122 may comprise pores or be otherwise structured to allow for bodily fluids to pass through the adhesive layer 122.
  • the absorbent layer 126 may comprise a disinfection substance that is excreted by said layer or pores of the absorbent layer 126, to be absorbed by the skin and/or surrounding tissue around the puncture site of the human or animal patient. This is to prevent infection around the puncture site and phlebitis.
  • the disinfection substance may constitute a separate disinfection layer (not shown in the figures).
  • the disinfection layer may be adapted to be arranged in direct connection to, i.e. over or under, the absorbent layer 126, and/or be adapted to be arranged above or over said adhesive layer 122 in relation to the body of said human or animal patient, i.e. further from the skin of the patient than the adhesive layer 122.
  • the absorbent layer 126 comprises a hydrogel.
  • the absorbent layer 126 may however comprise any available absorbent material suitable for the purpose, for example one or more Gauze swabs, absorbent dressing Evercare, Mesoft, non-adherent dressing, one or more compresses or superabsorbent wound dressing.
  • the fixation dressing 120 comprises a top protective layer 124.
  • This top protective layer 124 is then arranged above or over the other layers, i.e. further from the skin of the patient than the other layers, such that the top protective layer 124 protects the other layers, the skin of the patient and the entry area of the IV tube 400, when this is covered by the fixation dressing 120.
  • the top protective layer 124 may comprise a non- permeable flexible or elastic material, and/or a water repellant or water-resistant material.
  • the material may in some embodiments be a fabric, a woven fabric, a plastic material or be made from fiber.
  • the top protective layer 124 covers at least the same surface area as the adhesive layer 122 and, if present, also at least the same surface area as the absorbent layer 126.
  • the top protective layer 124 may be combined with any combination of the other layer described herein, for example as illustrated in the example embodiments of Figures 3C, 3D, 3E or 3G, further described below.
  • the fixation dressing 120 further comprises a bottom protective layer 128 which is configured to protect the adhesive layer.
  • the bottom protective layer 128 is further configured to be removed, partly or fully, before the fixation dressing 120 is attached to the skin of the human or animal patient.
  • This bottom protective layer 128 is then arranged below or under the adhesive layer 122, such that the bottom protective layer 128 protects the adhesive layer 122 before attachment of the fixation dressing 120.
  • the bottom protective layer 128 may be structured to be removed in one piece. Alternatively, the bottom protective layer 128 may be divided into two or more parts, of which at least two may partly overlap. The two or more parts of the bottom protective layer 128 may be structured to be removed separately.
  • the bottom protective layer 128 may be combined with any combination of the other layer described herein, for example as illustrated in Figures 3D, 3F, 3G or 3H.
  • the layered structure may be structured in any of the following manners:
  • a layered structure comprising, in consecutive order from the bottom up: an adhesive layer 122; an absorbent layer 126; and a top protective layer 124, as shown in Figure 3C.
  • a layered structure comprising, in consecutive order from the bottom up: a bottom protective layer 128; an adhesive layer 122; an absorbent layer 126; and a top protective layer 124, as shown in Figure 3D.
  • a layered structure comprising, in consecutive order from the bottom up: an adhesive layer 122 and a top protective layer 124, as shown in Figure 3E.
  • a layered structure comprising, in consecutive order from the bottom up: a bottom protective layer 128 and an adhesive layer 122, as shown in Figure 3F.
  • a layered structure comprising, in consecutive order from the bottom up: a bottom protective layer 128; an adhesive layer 122 and a top protective layer 124, as shown in Figure 3G.
  • a layered structure comprising, in consecutive order from the bottom up: a bottom protective layer 128; an adhesive layer 122 and an absorbent layer 126, as shown in Figure 3H.
  • the different layers of the fixation dressing 120 are preferably of the same shape as each other and cover essentially the same surface area. However, it is also conceivable that some layer covers a smaller area than others.
  • the overall shape of the supportive element is an essentially flat structure, and can be any suitable shape.
  • Figure 6A illustrates attachment of the fixation device 100 to the limb 500 of the patient, in this example illustrated as an arm of a human.
  • the fixation dressing 120 may be foldable in relation to the elongated member 110 along the longitudinal side 118 of the third portion 116, into a second position.
  • This is indicated in Figure 6A by the dotted line showing the original position of the fixation dressing 120 before it was folded along the longitudinal side 118 of the third portion 116, the dotted arrow indicating the folding motion, and the fixation dressing 120 in its second position, i.e. after folding.
  • the arrow 110 indicates that when the fixation dressing has been folded into its second position, the elongated member 110 is located under the fixation dressing 120, i.e.
  • the folding option is especially useful when the fixation device 100 is placed close to the planned insertion site for the IV tube 400, such that the fixation dressing could block the entry of the vein, or artery, with the IV tube 400 if folding was not enabled.
  • the folding possibility advantageously enables health care personnel to place the fixation device 100 closer to the intended entry point for the IV tube, or close to any other medical equipment or item attached to the limb 500 that may otherwise be obstructed by the fixation device 120 during entry of the IV tube into the vein or artery.
  • the elongated member 110 may be tightened around the limb 500 to enable easier visualization of a vein or blood vessel to penetrate with a needle 410. Thereafter, the needle tip 401 of an IV tube 400 is introduced into the selected vein or blood vessel, where after the needle 410 is slightly retracted and used as guide to introduce the IV tube into the vessel, according to methods known in the art.
  • the fixation dressing 120 is folded back, if it was previously folded, and any bottom protective layer 128 that may be present on the fixation dressing 120 is removed. Thereafter, the fixation dressing 120 is attached to the skin of the human or animal patient.
  • the attachment location of the fixation dressing 120 is preferably selected such that the fixation dressing 120, once attached, covers the wings 402 of the IV tube 400, to provide a secure attachment of the IV tube 400.
  • Figure 6B also shows an IV infusion line 504 which has been introduced into the end 404 of the IV tube 400.
  • the elongated member 110 is loosened, or completely opened, by untightening the pulling force that is applied around the limb 500, or opening the fastening element.
  • the elongated member 110 can then be separated from the fixation dressing 120 by hand force. The separated parts are illustrated in figure 6C.
  • the separation of the elongated member 110 from the fixation dressing 120 may be performed before the fixation dressing 120 is attached to the skin of the patient. This is useful if the planned insertion site of the IV tube 400 and the area where the elongated member 110 is fastened around the limb 500 are far from each other. For example, in one or more embodiments it may be advantageous to attach or fasten, and tighten, the elongated member 110 at a proximal part of the limb 500 to obtain strong stasis. In the non-limiting illustrative examples of the figures this may for example correspond to fastening the elongated member 110 to an upper arm.
  • the entry point for the IV tube 400 may further be advantageous to select the entry point for the IV tube 400 to be at a more distal part of the limb 500, for example the back of the hand of the patient limb 500 illustrated in the example of the figures.
  • the elongated member 110 and the entry point will be located at a distance from each other that is too large to enable fixation of the IV tube 400 by the fixation dressing 120, if the fixation dressing 120 is attached to the skin of the human or animal patient at its present location.
  • the fixation dressing 120 and the elongated member 110 can be separated by pulling them apart before the fixation dressing 120 is attached to the skin of the patient, the health care personnel is enabled to fasten the elongated member 110 at a distance from the intended entry point of the IV tube 400, but still have the fixation dressing 120 within reach for the fixation step, since it is detachably attached to the elongated member 110.
  • the health care personnel do not have to hold the fixation dressing 120 while fastening the elongated member 110. Neither do they have to reach far to obtain it, or risk forgetting the elongated member 110 and having to get up to find it in a cabin or drawer after having attached the elongated member 110.
  • the detachment of the elongated member 110 from the fixation dressing 120, along the border or side 118, or along the second, cutaneous surface 115 of the third portion 116, in the different manners described herein, is irreversible.
  • the detached elongated member 110 can be reattached to the fixation dressing 120 along the same border 118; the same first, non-cutaneous surface 113; or the same second, cutaneous surface 115, of the third portion 116.
  • FIG. 6D one or more embodiments for providing further improved fixation and securing of the fixation dressing 120 to the limb 500 of the patient will be described.
  • the elongated member 110 is further configured to, after detachment from the fixation dressing 120, be attached around the limb 500 of the human or animal patient at a second location, to provide further fixation and securement of the IV tube 400 and/or IV infusion line.
  • the second location may be different from the first location.
  • Figure 6D three non-limiting alternatives for the second location are illustrated, by the dotted outlines of the elongated member 110 in three versions.
  • the limb 500 is an arm of a human patient
  • the first location is at the wrist of the human patient
  • the second location is exemplified as being located at the hand, the wrist and/or across the underarm of the human patient.
  • the second location may be selected such that the elongated member 110 is attached across at least a part of the fixation dressing 120, to provide further fixation and securement of the IV tube 400, by reducing the risk of dislodgement due to pulling of the IV tube 400.
  • the second location is further selected such that elongated member 110, when attached to the limb 500 in the second location, covers at least part of the cutout portion 121. This is useful because the area of the cut out 121 of the fixation dressing 120 represents a weak point of the dressing where the IV tube might be pulled out if a dragging or pulling force is applied.
  • the second location is selected such that the elongated member 110 is attached across at least a part of the IV tube 400. In alternative embodiments, the second location is selected such that the elongated member 110 is attached under the IV tube 400 and at the same time covers at least part of the cutout portion 121.
  • the second location may be selected such that the elongated member 110 is attached across at least a part of the IV line 504, thereby providing further fixation and securement of the IV tube 401 by reducing the risk of dislodgement due to pulling of the IV line 504.
  • the elongated member 110 may be configured to be divided into two or more sections, for example into two, three, or four sections.
  • each of the resulting sections may be configured to be attached around the limb 500 of the human or animal patient, according to any of the attachment options presented herein, to provide further fixation and securement of the IV tube 401 by reducing the risk of dislodgement due to pulling of the IV tube 400 or the IV line 504.
  • the elongated member may be long enough to be divided into two, three or four sections, wherein each section is long enough to wrap around the limb 500 of the human or animal patient, and wherein each section comprises attachment means for attaching the section to the skin of the patient, and/or to attach the ends of the section to each other once the section has been wrapped around the limb 500 of the patient.
  • the attachment means may be provided by means of adhesive. The division of the elongated member 110 into two or more sections may be done before removal of a possible protection layer covering an adhesive layer, according to any of the relevant embodiments described herein.
  • the elongated member 110 may be configured to be divided into two or more sections via a respective one or more“tear off edge” or section border between the sections of the elongated member 110.
  • Each section is in these embodiments configured to be detachable from its neighboring section or sections by hand force, via the respective section borders.
  • the detachment may be enabled by means the border being defined by of at least one of perforations, indentions, punching, stitching, welding and adhesive.
  • each section may be attached around the limb 500 at the same or at a different (second, third, fourth etc.) location compared to any of the other sections.
  • the elongated member 110 or one or more sections of the elongated member 110, is configured to be attached around the limb 500, at the second location, via said first and second portions 112, 114, in any known manner, for example according to any of the manners described in connection with Figures 1A and 1 B.
  • the elongated member 110 further comprises an adhesive layer on at least one of the first, non-cutaneous surface 113 and the second, cutaneous surface 115.
  • the adhesive layer is configured to be attachable to the skin of the patient and to the first, non-cutaneous surface 117 of the fixation dressing 120, when the fixation dressing 120 is attached to the limb 500.
  • the elongated member 110 is in these embodiments configured to be attached around the limb 500, at the second location, via the adhesive layer.
  • the adhesive layer may be distributed over all or a part of the at least one first and second surface 113, 115 of the elongated member 110.
  • the elongated member 110 may further comprise a protective layer covering the adhesive layer, the protective layer being configured to be removed, partly or fully, before attachment of the elongated member 110 in the second location.
  • the protective layer may be structured to be removed in one piece.
  • the protective layer may be divided into two or more parts, of which at least two parts may optionally partly overlap. The two or more parts of the protective layer may in this case be structured to be removed separately.
  • fixation device 100 may be used in combination with any of the embodiments presented herein.
  • Figure 7 shows a schematic overview of a medical kit 300 according to one or more embodiments, comprising a kit package 310 configured to enclose a fixation device 100 according to any of the embodiments presented herein and at least one of: one or more disinfection wipes 320 for washing the skin of a patient; an IV tube to insert into a blood vessel; and a syringe prefilled with a saline solution.
  • the health care personnel thus get all the essential equipment, i.e. fixation dressing 120 and the elongated member 110 in one pack/solution.
  • everything needed for the IV tube procedure is thereby accessible to the health care personnel in the same medical kit.
  • the kit package 310 is flat, which is enabled by the components enclosed therein all being substantially flat.
  • the kit 300 is single use and/or sterile.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un dispositif de fixation (100) pour fixer et assujettir un tube intravasculaire, intraveineux, et une trousse médicale (300) comprenant un tel dispositif de fixation (100). Le dispositif de fixation (100) comprend un élément allongé souple (110) comportant une première partie (112) et une seconde partie (114) configurées pour être attachées l'une à l'autre, l'élément allongé (110) étant configuré pour être fixé autour d'un membre (500) d'un patient humain ou d'un animal à un premier emplacement, par l'intermédiaire desdites première et seconde parties (112, 114). Le dispositif de fixation (100) comprend en outre un pansement de fixation (120), comprenant au moins une couche adhésive (122) configurée pour être fixée à la peau du patient, le pansement de fixation (120) étant en outre fixé de manière amovible à l'élément allongé (110) à une troisième partie (116) de l'élément allongé (110). L'élément allongé (110) est en outre configuré pour être serré autour du membre (500) afin de fournir une stase vasculaire, ce qui permet d'introduire plus facile d'un tube intraveineux.
PCT/EP2020/056099 2019-03-08 2020-03-06 Dispositif de fixation pour un tube intravasculaire WO2020182686A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE1950298-8 2019-03-08
SE1950298A SE543141C2 (en) 2019-03-08 2019-03-08 Fixation device for an intravascular tube

Publications (2)

Publication Number Publication Date
WO2020182686A1 true WO2020182686A1 (fr) 2020-09-17
WO2020182686A9 WO2020182686A9 (fr) 2021-03-25

Family

ID=69780208

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2020/056099 WO2020182686A1 (fr) 2019-03-08 2020-03-06 Dispositif de fixation pour un tube intravasculaire

Country Status (2)

Country Link
SE (1) SE543141C2 (fr)
WO (1) WO2020182686A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114642801A (zh) * 2022-03-24 2022-06-21 南方医科大学珠江医院 新生儿无创cpap配套管道及鼻塞固定装置及制作方法
DE102022001026A1 (de) 2022-03-25 2023-02-16 Michael Lebert Schutz für periphere Venenkatheter (Venenverweilkanüle)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5897519A (en) * 1997-03-11 1999-04-27 Tapeless Technologies, Inc Intravenous securing device and secondary wound dressing
US5916199A (en) * 1996-07-11 1999-06-29 Miles; John E. Tapeless tubing anchoring system with intravenous applications
WO2012012301A2 (fr) * 2010-07-18 2012-01-26 Fasttrack Medical Solutions Llc Ancre intraveineuse unitaire réduisant la tension (iv)
US20130150796A1 (en) * 2011-12-07 2013-06-13 Becton, Dickinson And Company Foldable iv catheter securement dressing for protecting against inadvertent contamination

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5916199A (en) * 1996-07-11 1999-06-29 Miles; John E. Tapeless tubing anchoring system with intravenous applications
US5897519A (en) * 1997-03-11 1999-04-27 Tapeless Technologies, Inc Intravenous securing device and secondary wound dressing
WO2012012301A2 (fr) * 2010-07-18 2012-01-26 Fasttrack Medical Solutions Llc Ancre intraveineuse unitaire réduisant la tension (iv)
US20130150796A1 (en) * 2011-12-07 2013-06-13 Becton, Dickinson And Company Foldable iv catheter securement dressing for protecting against inadvertent contamination

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114642801A (zh) * 2022-03-24 2022-06-21 南方医科大学珠江医院 新生儿无创cpap配套管道及鼻塞固定装置及制作方法
DE102022001026A1 (de) 2022-03-25 2023-02-16 Michael Lebert Schutz für periphere Venenkatheter (Venenverweilkanüle)

Also Published As

Publication number Publication date
SE543141C2 (en) 2020-10-13
WO2020182686A9 (fr) 2021-03-25
SE1950298A1 (en) 2020-09-09

Similar Documents

Publication Publication Date Title
US10350388B2 (en) Peripheral intravenous and arterial catheter securement device
US5897519A (en) Intravenous securing device and secondary wound dressing
US8123681B2 (en) Medical appliance stabilization device and method for using same
US8876777B2 (en) Safe needle methods, apparatus, and systems
US5019050A (en) Securing device and method
US20170136214A9 (en) Intravenous splint cover and associated methods
WO2020182686A1 (fr) Dispositif de fixation pour un tube intravasculaire
EP1962763A2 (fr) Pansement stabilisant
US11969160B2 (en) Tissue retention devices and methods
CN112006759A (zh) 血管鞘管固定件、导管无菌罩及其组件
US20180263655A1 (en) Guidance device for ultrasonography guided device placement
CN206239866U (zh) 一种固定中心静脉导管的敷贴
CN212438787U (zh) 血管鞘管固定件、导管无菌罩及包含其的血管鞘管组件
US20120265148A1 (en) Body line management system
CN214970290U (zh) 静脉留置针保护网套
CN216257791U (zh) 股动、静脉穿刺点弹力带扣反折增强包扎带
CN219517404U (zh) 一种儿童护理用留置针固定器
CN221469136U (zh) 病号服
CN219721632U (zh) 一种带有观察窗的血液透析临时颈静脉导管安全型固定贴
CN213249465U (zh) 透析导管专用止血带
CN213665475U (zh) 外科手术辅助装置
CN210844674U (zh) 一种留置针固定装置
CN211751519U (zh) 一种输液固定装置
US20220355079A1 (en) A sanitary dressing
CN205144869U (zh) 医用敷料

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20710130

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205A DATED 03.01.2022)

122 Ep: pct application non-entry in european phase

Ref document number: 20710130

Country of ref document: EP

Kind code of ref document: A1