External catheter stabilization device

Abstract

To provide an external catheter stabilization device that stabilizes and retains a catheter tube.SOLUTION: The external catheter stabilization device comprises: a base portion 40 configured to be adhesively attached at a patient 60; a retention device 50 configured to retain a catheter tube 20 therein; and a pivot component element pivotally mounting a retention component element to the base portion so as to allow for pivotal movement of the retention device 50 about a pivot axis generally perpendicular to the patient 60 to which the base portion 40 is mounted. The retention device 50 includes a guide pin protruding therefrom and spaced apart from the pivot component element. The pivotal movement of the retention device 50 relative to the base portion 40 is limited to a selected range via engagement of the guide pin of the retention device 50 with the arcuate slot at the base portion.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 826,057, filed Mar. 29, 2019, and U.S. Provisional Application No. 62 / 783,385, filed Dec. 21, 2018, which are hereby incorporated by reference in their entirety.

[0002] The present invention generally relates to the control and stabilization of catheters and other similar generally flexible tubes composed of medical - grade plastics or other known polymeric materials, and its purpose is to facilitate medical procedures related to discharging or making it possible to discharge body fluids or substantially liquid and flowing substances from the inside of the human body to the outside for patients undergoing treatment and medical procedures for continuous, periodic, or one - time use.

Background Art

[0003] When a patient / physician attempts to use a catheter or similar device to drain fluid from the body, if the catheter becomes dislodged at a surgically prepared stoma site, it can significantly increase the risk of infection and irritation to the surrounding skin and internal organs. Thus, various solutions have been proposed to secure the catheter in a predetermined position of the patient. For example, in the case of a Mitrofanoff procedure, a Foley - type catheter leaves an inflated balloon - like device inside the bladder, which can cause bladder spasms when the device moves, collides with, or contacts the inner wall of the bladder. This can cause severe pain and discomfort to the patient.

[0004] There are other types of catheter stabilization devices, some of which are not placed on stoma sites where there is a significant risk that the catheter will be accidentally or otherwise inadvertently withdrawn from the bladder or stoma passage. These types of devices tend to provide only partial solutions and are not adequate due to the inherent limitations of their design. It is typically necessary to tape the catheter directly to the skin surface, but this is not an appropriate or long-term solution for patients who need to manually drain the bladder over an extended period, which is generally dictated by the specific case of each patient or the length of the healing process. An installed catheter can be easily and inadvertently pulled or snagged if not carefully monitored or otherwise carefully protected. In severe cases, the catheter can be torn out, causing severe pain, the possibility of infection, skin irritation, and the potential for replacement or emergency repair surgery. SUMMARY OF THE INVENTION

[0005] The present invention provides an external catheter stabilization device that can be positioned on a patient's skin (such as on the patient's leg), enabling the patient to move without pulling on the catheter tube at the location where the catheter tube enters the patient's body by allowing flexibility or pivoting of the tube at the attachment portion on the patient's skin.

[0006] According to one aspect of the present invention, an external catheter stabilization device includes a pedestal portion configured to be adhesively attached to a patient, a retention component configured to retain a catheter tube therein, and a pivoting component that pivotally attaches the retention component to the pedestal portion. The pivoting component is attached to the retention component such that the retention component is pivotally movable about a pivot axis that is generally perpendicular or orthogonal to the skin of the patient to whom the pedestal portion is attached. The pivotal movement of the retention component relative to the pedestal portion is restricted to a selected range by engaging a guide pin of the retention component with an arcuate slot hole of the pedestal portion. The arcuate slot hole may extend 180 degrees about the pivot axis, thereby restricting the pivotal movement of the retention component relative to the pedestal portion to approximately 180 degrees.

[0007] According to another aspect of the present invention, an external catheter stabilization device includes a pivoting component that pivotally attaches a retention component to a pedestal portion such that the retention component is pivotally movable about a pivot axis that is generally perpendicular to a patient to whom the pedestal portion is attached. The pivoting component removably attaches the retention component to the pedestal portion. The retention component may include an openable and closable housing configured to limit or prevent the retention component from detaching from the pedestal portion while the housing is closed.

[0008] These and other objects, advantages, purposes, and features of the present invention will become apparent by considering the following specification in conjunction with the drawings.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0067] Referring now to the drawings and the exemplary embodiments shown therein, an external catheter stabilization (ECS) device 10 provides support and restraint of a catheter tube 20 at a patient 60.

[0068] Figs. 1 - 7 show a catheter fixation device 10, 10a including a skin - adhesive patch 30 (in some implementations roughly e.g., about 4 inches×about 4 inches (102 mm×102 mm)), semi - flexible and thin pedestals 40, 40a attached to the skin - adhesive patch 30, and catheter stabilization device storage holders 50, 50a (shown in a closed state in Fig. 2 and an open state in Fig. 3) that capture and enclose a typical Foley - type catheter "Y - junction". The holder 50 may be made of a somewhat rigid plastic, for example, as one part incorporating a molded plastic "living" hinge that allows the opening and closing of the holder 50 and at least one molded plastic latch mechanism that fixes the holder 50 in the closed position. As shown in Fig. 4, a through - hole generally centered in the wall at the pedestal portion of the holder 50a engages a "pin - head - like protrusion" or pin near or at the center of the thin pedestal 40a, providing an engagement where the hole of the holder 50a and the pin of the pedestal 40a are simply snap - coupled to allow the holder 50a to rotate relative to the pedestal 40a. Thus, the adhesive patch 30 (a skin - compatible adhesive) is adhered to the skin of the patient 60, and the pedestal 40a (including semi - flexible urethane or the like) is attached to the skin - adhesive patch 30 (either with or without a skin - compatible adhesive via an adhesive). The pedestal 40a includes a pivoting pin or component or structure that snap - couples through the pivot hole of the holder 50a, whereby the two catheter tubes 20, 20a are positioned at the holder 50a and are fixed there when the holder 50a is closed. Optionally, the fixation device may include a pivoting component (e.g., a pin or similar structure) protruding from the wall of the pedestal portion of the fixation device. The pivoting component may snap - couple through a mating pivot hole in the pedestal and engage to rotate.

[0069] Device 10a provides a single axis of rotation of the immobilization device 50a relative to the patient's leg while supporting the catheter 20a, which is required for the patient 60's body movement. This arrangement serves to support and stabilize the catheter 20a so as not to impart unnecessary stress, strain, or interference to the patient's urethra and the Foley-type balloon within the patient 60's bladder.

[0070] Optionally, the immobilization device 50 may include a series of small flexible protrusions on one or more of the inward-facing surfaces of the generally oval opening or passage of the immobilization device 50 through which the catheter tube 20 passes. The small flexible protrusions may be provided to increase friction or create a desired amount of friction between the catheter tube 20 and the closed immobilization device 50. This may help the immobilization device 50 better accommodate a wider range of catheter diameters, such as between diameters of 10 to 22 French catheter sizes, including the upper and lower limits.

[0071] Referring to FIGS. 8-10, the devices 10, 10b of the present invention may have a securing device 50, 50b in the form of a two-way clip having pins by which the clip is pivotally attached to the bases 40, 40b such that the tube 20a is simply snap-coupled within two receiving clips of the device 10b. The two-way clip includes C-shaped clips at each end, each C-shaped clip having a generally cylindrical receiving portion or passage with a predetermined inner diameter. The inner diameter dimension at each C-shaped clip is selected by design to frictionally engage with the outer diameter of a catheter tubing of a predetermined size (e.g., 10 to 22 French) to provide a desired degree of frictional engagement and fixation of the catheter within the end portions of this pivoting clip. A set of preconfigured clips designed for various standard diameters within the envisioned range can be made available for the user to optionally utilize. The various sized clips produced can be optionally identified, for example, by a stamped number corresponding to the catheter size, different colors of the injection molded plastic structure, or by other similar and suitable means for rapid and useful identification for the user. The user then simply selects a clip of the size suitable for a particular application and snap-couples the clip to the base.

[0072] The overall product strategy and advantages using such embodiments is to secure and control a catheter 20a directly inserted into the urethra of a patient 60. The device 10b may be appropriately, securely, and consistently fixed on or near the skin surface of the patient 60, such as via one or more adhesive pads using a specific adhesive selected for use with human skin. This provides an improvement over randomly using, for example, simple and often generic medical tapes, or simple and generic multi-purpose adhesive patches. There is one problem, which is when these materials are applied to the patient's skin by medical staff (or optionally, by the patient themselves) in random locations on the patient, in random quantities and / or amounts. This is a problem that is known to often occur and is a health risk in the repeated attempts to properly (but inconsistently) secure the catheter tube to and with the patient. Using various types of generic medical tapes and adhesive patches can likely result in inconsistent or improper fixation of the catheter to any given patient. Such tapes or adhesives tried by the patient, while attempts are made to identify solutions for improper fixation, can be particularly troublesome if the patient or catheter user tends to move around while in bed, asleep, awake, standing, or walking, or if the patient or user is otherwise somewhat active.

[0073] In attempting to secure a catheter to a patient, the use of medical tape by completely wrapping it around a leg, an arm, or even around the abdomen of the body can result in discomfort and pain. This is particularly true with respect to the harmful skin reactions to various types of random adhesives and adhesives that may not be ideal for such purposes. In other more extreme cases, inappropriate use of tape that simply binds the entire circumference of a part of the body can potentially restrict the free flow of body fluids and / or blood throughout the body. Such conditions can potentially cause more serious medical complications, especially with respect to young children and elderly patients who may have to use a catheter for various health-related reasons.

[0074] Another overall product strategy and advantage using the device of the present invention is to secure and control a catheter that is surgically realized in a body opening or, for example, directly inserted into a stoma opening that leads to the bladder through the abdomen. Another overall product strategy and advantage using such an embodiment is to secure and control a catheter that is directly inserted into the urethra with the option of being fully inserted into the bladder for drainage purposes and / or, for example, partially retracted from the bladder for non-drainage purposes when a Foley-type balloon is not utilized within the bladder. Eliminating the need to use a Foley-type balloon within the bladder often eliminates a major cause of discomfort and, in some cases, can result in a period of excruciating pain for the patient.

[0075] Equally important for the comfort of a patient using a catheter is that the device 10b may provide a mechanical strain relief point for the patient 60 between the urethra and the distal end of the catheter tube 20a. The device 10b can provide a relatively limited but free rotation or pivoting rocking of the catheter tube, and thus can provide a desired amount of essentially free movement of the catheter 20a at its strain relief attachment point. Also, the device 10b can provide either (pinch valve) control of the flow or no flow of the catheter tube 20a, and optionally enable this, separate from selectively inserting the catheter 20a into the bladder, retracting the catheter 20a from the bladder, or partially retracting it. A typical and separate catheter pinch valve (not shown in any figure or embodiment herein) when engaged applies a constricting force to the catheter tube, temporarily inhibiting or preventing the flow of liquid through the catheter. The device 10b provides a preferred match with most commercially available pinch valves, straight catheters, and the diameters of various currently available flexible medical tubing materials.

[0076] The devices 10, 10c shown in FIGS. 11 - 15 provide similar functions, but the formed retention devices 50, 50c are formed to correspond to the shape of a Y - shaped junction and retain the catheter tube 20a there without pinching it, while at the same time providing a more secure fixation of the catheter tube at the patient's location. Here, one branch of the Y - shaped junction terminates near the formed retention devices 50, 50c, for example, arranging and / or facilitating access to a branch for inflating or deflating the balloon of a Foley - type catheter.

[0077] The devices 10, 10d shown in FIGS. 16 to 22 provide similar functions, but the formed immobilizing devices 50, 50d are formed to correspond to the shape of the three-tube joint of the catheters 20, 20b, and are adapted to immobilize there without clamping the tubes. Similarly, the devices 10, 10e shown in FIGS. 23 to 25 provide similar functions, but the box-shaped immobilizing devices 50, 50e immobilize the three tubes of the catheters 20, 20b there in the same manner as described above with respect to the embodiments of FIGS. 1 to 10.

[0078] The apparatuses 10, 10f in FIG. 26 are provided with an alternative "keyhole-shaped design" at the rotation holes of the pedestals 40, 40c of the fixing apparatuses 50, 50f. A protrusion that is partially keyhole-shaped (or in another suitable shape) may be provided at the top cover (inside), and when closed, it may block the larger part of the keyhole (at the bottom cover of the fixing apparatus). The larger part of the keyhole may have a substantially circular shape and may have a diameter large enough for the head of the pivot pin to pass through. The smaller part of the keyhole is substantially narrower than the head of the pivot pin while having a width sufficient to accommodate the shaft of the pivot pin. Thus, the fixing apparatus may be attached to the pedestal by passing the head of the pivot pin through the larger part of the keyhole and then repositioning the fixing apparatus relative to the pedestal so that the shaft of the pivot pin is positioned in the smaller part of the keyhole. When closed, the fixing apparatus may hold the position of the shaft of the pivot pin within the smaller part of the keyhole and prevent or inhibit the head of the pivot pin from passing through the larger part of the keyhole. For example, in this fixing apparatus, by enabling the use of a head with an enlarged end of the pivot pin, it better resists the possibility of coming out of the hole in the fixing apparatus 50f. This feature may make it even easier to remove and replace the fixing apparatus 50f at the pivot attachment part for pivot inspection, cleaning, and inspection and optional replacement of the fixing apparatus 50f simply by opening the top cover and removing the pivot pin from the keyhole opening of the fixing apparatus. Also, this feature may provide for optional replacement with a fixing apparatus for replacement without necessarily removing and replacing the pedestal, catheter, or adhesive skin patch. Therefore, such design features can provide advantages of ease of maintenance and convenience to both patients and medical staff, and may further promote the possibility of reducing the time of medical staff in medical facilities and the cost of patient care.

[0079] The apparatuses 10, 10g shown in FIGS. 27A - 29B provide the same functions as the embodiments described above and shown in FIGS. 1 - 25, but the pedestals 40, 40d have arcuate slot holes 42, and these slots extend about 180 degrees around the pivot at the rotation holes of the pedestal 40d. The securing devices 50, 50g have guide pins 52, 52a, and these guide pins project from the securing devices 50, 50g at a distance from the pivot and engage slidably or movably with the slot holes. The arcuate slot holes may extend entirely or partially through the pedestal. That is, the slot holes may be notches formed on the surface of the pedestal by etching or other methods to a depth sufficient to maintain the guide pins within the slots when the pedestal rotates. Optionally, the guide pins may be spring - retained, and the springs exert a force to engage and / or maintain the guide pins in the slot holes, for example, along the longitudinal axis of the guide pins. When the securing device 50g rotates relative to the pedestal 40d via the rotation / pivot pins 54, 54a on the securing devices 50, 50g rotatably engaged in the holes 44 near the center of the pedestal 40d, the guide pins may slide or move along the length of the slot holes. The length of the slot holes may limit or set the range of rotation of the securing device 50g, for example, when the guide pins abut against the ends of the slots, the rotation of the securing device 50g is prohibited. Optionally, the slot holes may be of any shape that allows the arcuate movement of the guide pins and limits or sets the degree of rotation of the securing device 50g. For example, the slot holes may be substantially circular or semi - circular openings or notches within the pedestal. The substantially circular or semi - circular openings or notches may have stops, i.e., ends, and these stops, i.e., ends, limit the movement of the guide pins within the range between the stops. For example, the stops may be positioned about 180 degrees apart and project inwardly from the ends of the substantially circular opening or notch to limit the movement of the guide pins within the range between the stops.

[0080] As shown in FIG. 28A, the slot holes may be disposed on one side of the pedestal 40d, that is, along the length of the pedestal 40d. For example, when the device 10g is adhered to the skin of the patient's right or left foot of the patient 60, the pedestal 40d will be oriented such that the slot holes face away from the center of the patient's body. That is, the orientation of the pedestal 40d on the right foot may be opposite to the orientation of the pedestal 40d on the left foot, or may be relatively upside down. Thus, the immobilization device may pivot about approximately 180 degrees, and by this pivoting, the upper end of the immobilization device can be made upward (when the guide pin is at the upper end of the slot hole), or downward (when the guide pin is at the lower end of the slot hole), or inwardly toward the center of the patient's body (when the guide pin moves along the slot hole between the upper end and the lower end). Thus, the present device realizes a controlled or restricted pivoting of the immobilization device, affecting a restricted movement of the catheter tubing within a restricted range. The restricted pivoting movement can suppress and prevent kinking and entanglement of the catheter tube when the patient is at rest or moving. Furthermore, the restricted pivoting movement may further facilitate the placement, and / or access, and / or maintenance of a branch portion of the catheter tube that terminates near the immobilization device, such as an inflation port of a Foley catheter.

[0081] The devices 10, 10h shown in FIGS. 30A - 32C provide the same functions as the embodiments shown in FIGS. 27A - 29B, but the formed immobilization devices 50, 50h are formed to correspond to the shape of the junction of a three - tube type or three - direction catheter, and are adapted to immobilize the tube there without clamping the tube.

[0082] The apparatuses 10, 10j shown in FIGS. 33A to 39C provide the same functions as the embodiments shown in FIGS. 27A to 29B, but the pedestals 40, 40e have slot holes disposed along different sides of the pedestal 40e, for example, along the width at the upper part of the pedestal. Similarly, the immobilizing devices 50, 50j may include guide pins slidably or movably engaged with the slot holes, and the guide pins may slide or move along the length of the slot holes when the immobilizing device 50j rotates relative to the pedestal 40e. Thus, the immobilizing device may pivot about 180 degrees, and by this pivoting, the upper end portion of the immobilizing device is directed inwardly (when the guide pins are at the respective side ends of the slot holes) toward the center of the patient's body, or outwardly (when the guide pins are at the opposite end portions of the slot holes) away from the center of the patient's body, or upwardly (when the guide pins move along the slot hole between the opposing end portions). Thus, the present apparatus provides a controlled or limited pivoting of the immobilizing device to enable a limited movement of the catheter tubing within a limited range. Optionally, the slot holes may be disposed at other locations on the pedestal, and / or the degree of rotation of the immobilizing device 50j relative to the pedestal 40e may be limited to a range less than 180 degrees (or optionally, a range greater than 180 degrees but less than 360 degrees).

[0083] The apparatuses 10, 10k including the holding devices 50, 50k shown in FIGS. 40 to 41C provide the same functions as the embodiments shown in FIGS. 27A to 29B, and it is not necessary to repeat the detailed consideration of the apparatuses in this specification. The holding devices 50, 50j and 50, 50k are mounted so as to pivot at the pedestal via pivot pins protruding from the holding devices and received through apertures in the pedestal, and the holding devices include guide pins, and these guide pins are movably disposed at an arcuate slot hole or the like, and this slot hole or the like limits the pivoting range of the holding device at the pedestal in the same manner as described above, for example. Alternatively, the holding device may be mounted so as to pivot at the pedestal via a pin protruding from the base and received through an aperture in the holding device (see FIGS. 54 to 60). The apparatuses including the holding devices shown in FIGS. 54 to 60 provide the same functions as the embodiments shown in FIGS. 33A to 41C, and it is not necessary to repeat the detailed consideration of the apparatuses in this specification.

[0084] The apparatuses 10, 10m shown in FIGS. 42 to 46C provide the same functions as the embodiments shown in FIGS. 33A to 41C, but the formed holding devices 50, 50m are formed to correspond to the shape of the three-tube joint and are adapted to hold there without clamping the tubes. The holding devices 50, 50m are mounted so as to pivot at the pedestal via pivot pins protruding from the holding devices and received through apertures in the pedestal, and the holding devices include guide pins, and these guide pins are movably disposed at an arcuate slot hole or the like, and this slot hole or the like limits the pivoting range of the holding device at the pedestal in the same manner as described above, for example. Alternatively, the holding devices 50, 50m may be mounted so as to pivot at the pedestal via pins protruding from the pedestal and received through apertures in the holding devices (see FIGS. 47 to 53). The apparatuses 10, 10m including the holding devices 50, 50m shown in FIGS. 42 to 46C provide the same functions as the embodiments shown in FIGS. 33A to 41C, and it is not necessary to repeat the detailed consideration of the apparatuses in this specification.

[0085] Optionally, and as shown in FIGS. 61-64, the device including the holding device and the pedestal portion has separate pivot components 60 (FIGS. 61 and 62), and these components may be snap-coupled to an aperture in the pedestal and snap-inserted into an aperture in the holding device to pivotally mount the holding device at the pedestal component. For example, the pivot component may be inserted through an aperture in the pedestal such that the wider end or flange of the pivot component engages the underside of the pedestal, and the pivot component may be snap-inserted into an aperture in the holding device (the end of the pivot component has a slotted hole that allows inward bending at the end for inserting the end into the aperture in the holding device). Alternatively, a separate pivot component 55 may be inserted through an aperture in the holding device and engaged or snap-mounted to the pedestal. In the exemplary embodiments of FIGS. 61-64, the holding device has the shape of a two-tube joint, but may be shaped or formed to correspond to, for example, the shape of a three-tube joint to hold therewithout clamping the tubes. The device including the holding device shown in FIGS. 61-64 provides a similar function as the embodiments shown in FIGS. 33A-60, such that a detailed discussion of the device need not be repeated herein.

[0086] Therefore, the adhesive patch 30 may be worn by adhesion to the patient's skin (e.g., via a suitable and skin-safe adhesive disposed on the underside of the patch that enables the patch to be adhered to the patient's skin and safely removed from the patient's skin), and the pedestal 40 may be worn by adhesion to the patch (e.g., by adhesively attaching the pedestal to the patch). The position of the pedestal relative to the patch may be set such that the patch is received at a slight recess on the upper surface of the adhesive patch (which may correspond to the shape or contour of the patch), which is done such that an aperture passing through the pedestal generally coincides with an aperture passing through the patch. The pivoting component may be inserted through the central aperture of the pedestal before attaching the pedestal to the patch and / or before attaching the patch to the patient, and the central hole of the patch and / or the thickness dimension of the pedestal provides a clearance for the pedestal flange of the pivoting component so that the pivoting component is spaced from the patient's skin when the patch is adhered to the patient. Then, a fixation device (e.g., a two-tube or three-tube fixation device) may be selected (e.g., a fixation device having a suitable form and size for a particular catheter tube to be fixed) and snap-coupled to the pivoting component, and then the catheter tube may be routed through the fixation device (when the fixation device is open), thereby snap-closing the fixation device to fix the tube at the device and enabling limited rotation or pivoting movement of the fixation device and the tube relative to the pedestal and the adhesive patch at the patient.

[0087] Accordingly, the device of the present invention is provided with a pivotable or adjustable attachment of a catheter tube to a patient such that when the patient moves, the device pivots to limit or substantially eliminate the possibility of the catheter tube being pulled, constricted, or pinched. This device may utilize aspects of the external catheter stabilization device described in U.S. Patent No. 10,086,168, which is hereby incorporated by reference in its entirety. Optionally, the device described herein may be the device of U.S. Patent No. 10,086,168, disposed at an opening surgically created in the body, i.e., at an opening of a stoma for example related to the bladder, and used in combination with a device for guiding a tube therefrom, and the device 10 described herein may also be used in combination with a device that is pivotally attached at a patient's leg (or optionally, at any preferred remote location from a surgically created opening, i.e., a stoma) to guide a drainage tube and to limit the preferred range of free pivotal movement when the tube extends towards a body fluid collection bag or container.

[0088] Changes and modifications in the specifically described embodiments can be made without departing from the principles of the present invention, and the present invention is intended to be limited only by the scope of the appended claims as construed in accordance with the principles of patent law, including the doctrine of equivalents. Disclosure of the Invention 1. A pedestal portion configured to be adhesively attached to a patient, A securing component configured to secure a catheter tube thereto, A pivotal component that pivotally attaches the securing component to the pedestal portion to enable pivotal movement of the securing component about a pivot axis generally perpendicular to the patient to whom the pedestal portion is attached, An external catheter stabilization device for stabilizing and securing a catheter tube, comprising: The securing component includes a guide pin that protrudes from the securing component and is spaced from the pivotal component, The pivotal movement of the immobilizing component relative to the pedestal portion is restricted to a selectable range via the engagement of a guide pin of the immobilizing component with an arcuate slot hole of the pedestal portion. External catheter stabilization device. 2. The external catheter stabilization device according to item 1, wherein the arcuate slot hole extends 180 degrees around the pivot axis to limit the pivotal movement of the immobilizing component relative to the pedestal portion to 180 degrees. 3. The external catheter stabilization device according to item 1, wherein the arcuate slot hole extends less than 180 degrees around the pivot axis to limit the pivotal movement of the immobilizing component relative to the pedestal portion to less than 180 degrees. 4. The external catheter stabilization device according to item 1, wherein when the pedestal portion is attached to the patient, the arcuate slot hole is disposed along a side portion of the pedestal portion on the side of the pivot axis. 5. The external catheter stabilization device according to item 1, wherein when the pedestal portion is attached to the patient, the arcuate slot hole is disposed along an upper portion of the pedestal portion above the pivot axis. 6. The external catheter stabilization device according to item 1, wherein the immobilizing component includes an openable and closable housing, and when the catheter tube is disposed at the housing and the housing is closed, the catheter tube is immobilized at the housing. 7. The external catheter stabilization device according to item 6, wherein the catheter tube includes a Y-shaped joint, and the housing is configured to receive and immobilize the Y-shaped joint. 8. The external catheter stabilization device according to item 6, wherein the catheter tube includes a three-way joint, and the housing is configured to receive and immobilize the three-way joint. 9. The external catheter stabilization device according to item 6, wherein the housing conforms to the shape of the catheter tube at the housing. 10. When the holding component has an elliptical opening and the catheter tube is disposed within the elliptical opening, a flexible protrusion configured to engage with the catheter tube, which is provided on the inner-facing surface of the elliptical opening, of the external catheter stabilization device according to item 1. 11. The external catheter stabilization device according to item 1, wherein the holding component includes one or more receiving clips, and the one or more receiving clips are configured to hold the catheter tube when the catheter tube is disposed within the one or more receiving clips. 12. The external catheter stabilization device according to item 1, further comprising a pinch valve, wherein when the catheter tube is held by the holding component and the pinch valve is engaged, the pinch valve applies a contraction force to the catheter tube. 13. The external catheter stabilization device according to item 1, wherein the pedestal portion is adhesively attached to an adhesive patch that adheres to the patient's skin. 14. The external catheter stabilization device according to item 1, wherein the pivoting component detachably mounts the holding component to the pedestal portion. 15. The external catheter stabilization device according to item 1, wherein the pivoting component is formed as part of the holding component and is received at an aperture of the pedestal portion. 16. The external catheter stabilization device according to item 1, wherein the pivoting component is formed as part of the pedestal portion and is received at an aperture of the holding component. 17. The external catheter stabilization device according to item 1, wherein the pivoting component includes a separate pivoting component formed separately from the holding component and the pedestal portion, and is received at an aperture of the pedestal portion and an aperture of the holding component. 18. A pedestal portion configured to be adhesively attached to a patient, a holding component configured to hold a catheter tube therein, A pivoting component that mounts the holding component pivotally to the pedestal portion to enable pivotal movement of the holding component about a pivot generally perpendicular to a patient on whom the pedestal portion is mounted; An external catheter stabilization device for stabilizing and holding a catheter tube, comprising: The pivoting component removably mounts the holding component to the pedestal portion; External catheter stabilization device. 19. The external catheter stabilization device according to item 18, wherein the holding component further comprises an openable and closable housing, and when the catheter tube is disposed at the housing and the housing is closed, the catheter tube is held at the housing. 20. The external catheter stabilization device according to item 19, wherein the housing is configured to enable removal of the holding component from the pedestal portion when the housing is open, and the housing is configured to prevent removal of the holding component from the pedestal portion when the housing is closed. 21. The pivoting component comprises a shaft and a head at an end of the shaft, the diameter of the head being larger than the diameter of the shaft, the housing comprising a rotating hole having a wide portion and a narrow portion, the wider portion being configured to allow passage of the head of the pivoting component, the narrower portion being configured to allow passage of the shaft of the pivoting component and to resist passage of the head of the pivoting component, and when the shaft of the pivoting component is disposed in the narrower portion of the rotating hole, the housing is configured to maintain the shaft of the pivoting component in the narrower portion of the rotating hole while the housing is closed. The external catheter stabilization device according to item 20. 22. The external catheter stabilization device according to item 18, wherein the pivotal movement of the holding component relative to the pedestal portion is restricted to a selected range through engagement of a guide pin of the holding component with an arcuate slot hole of the pedestal portion. 23. The external catheter stabilization device according to item 18, wherein when the catheter tube is disposed within the fixing component, a flexible protrusion configured to engage with the catheter tube is provided on the inward-facing surface of the fixing component. 24. The external catheter stabilization device according to item 18, wherein the pivoting component is formed as a part of the fixing component and is received at the aperture of the pedestal portion. 25. The external catheter stabilization device according to item 18, wherein the pivoting component is formed as a part of the pedestal portion and is received at the aperture of the fixing component. 26. The external catheter stabilization device according to item 18, wherein the pivoting component comprises a separate pivoting component formed separately from the fixing component and the pedestal portion, and is received at the apertures of the pedestal portion and the fixing component.

Claims

1. An external catheter stabilization device, comprising: a pedestal portion configured to be attached to a patient by adhesion; a securing component configured to secure a catheter tube thereto; a pivotal component that pivotally attaches the securing component to the pedestal portion and enables pivotal movement of the securing component about a pivot extending outward from the patient to whom the pedestal portion is attached, the pivotal component including a shaft and a head at an end of the shaft, the diameter of the head being larger than the diameter of the shaft; and the securing component includes a housing having a lower cover and an upper cover, the housing being openable and closable, and when the catheter tube is disposed in the housing and the housing is closed, the catheter tube is secured at the housing; the lower cover of the housing has a keyhole including a wide portion and a narrow portion, the wide portion being configured to allow the head of the pivotal component to pass through the lower cover of the housing, the narrow portion accommodating the shaft of the pivotal component and resisting passage of the head of the pivotal component through the lower cover of the housing at the narrow portion; by accommodating the head of the pivotal component through the wide portion of the keyhole and moving the shaft of the pivotal component along the keyhole to dispose the shaft of the pivotal component in the narrow portion of the keyhole, the lower cover of the housing is positioned on the pedestal portion; when the shaft of the pivotal component is disposed in the narrow portion of the keyhole, and the housing is closed through engagement between the pivotal component and the upper cover of the housing, the shaft of the pivotal component is maintained in the narrow portion of the keyhole; the upper cover of the housing includes a protrusion, and when the housing is closed, the protrusion is at least partially disposed in the wide portion of the keyhole to limit movement of the pivotal component along the keyhole toward the wide portion of the keyhole; An external catheter stabilization device.

2. The lower cover of the housing is configured to be able to remove the securing component from the pedestal portion when the housing is open and the protrusion is moved away from the wide portion of the keyhole. The external catheter stabilization device according to claim 1.

3. The pivotal movement of the immobilizing component relative to the pedestal portion is restricted to a selectable range via engagement of a guide pin of the immobilizing component with an arcuate slot hole of the pedestal portion, and the guide pin is spaced apart from the pivotal component. The external catheter stabilization device according to claim 1.

4. When the pedestal portion is attached to the patient, the arcuate slot hole is disposed along a side portion of the pedestal portion lateral to the pivot axis. The external catheter stabilization device according to claim 3.

5. The arcuate slot hole extends 180 degrees around the pivot axis to limit the pivotal movement of the immobilizing component relative to the pedestal portion to 180 degrees and facilitate the placement of a branch portion of the catheter tube that terminates near the immobilizing component. The external catheter stabilization device according to claim 3.

6. The arcuate slot hole extends at an angle less than 180 degrees around the pivot axis to limit the pivotal movement of the immobilizing component relative to the pedestal portion to less than 180 degrees and facilitate the placement of a branch portion of the catheter tube that terminates near the immobilizing component. The external catheter stabilization device according to claim 3.

7. When the pedestal portion is attached to the patient, the arcuate slot hole is disposed along an upper portion of the pedestal portion adjacent to the pivot axis. The external catheter stabilization device according to claim 3.

8. The catheter tube includes a Y-shaped junction, and the housing is configured to receive and immobilize the Y-shaped junction. The external catheter stabilization device according to claim 1.

9. The catheter tube includes a three-way junction, and the housing is configured to receive and immobilize the three-way junction. The external catheter stabilization device according to claim 1.

10. The housing conforms to the shape of the catheter tube received and immobilized therein. The external catheter stabilization device according to claim 1.

11. The housing includes a flexible protrusion configured to engage the catheter tube when the catheter tube is disposed within the housing and the housing is closed. The external catheter stabilization device according to claim 1.

12. The pedestal portion is adhesively attached to an adhesive patch that adheres to the patient's skin. The external catheter stabilization device according to claim 1.

13. wherein the pivotal component is formed as a part of the pedestal portion The external catheter stabilization device according to claim 1.

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