Medical Tube Securement Devices and Related Products and Methods

Abstract

A medical tube retention device for securing a medical tube includes a variable length retention sleeve having a retention portion that changes an internal passage cross-sectional area as the length of the retention sleeve changes, the internal passage cross-sectional area of ​​the retention portion being capable of receiving the medical tube when the internal passage cross-sectional area is larger, while gripping and retaining the medical tube when the internal passage cross-sectional area is smaller, and a bent sleeve retainer being selectively engageable to retain the retention sleeve and the secured medical tube in a bent configuration.

Description

[Technical field]

[0001] The present invention relates to the fastening of medical tubing, such as medical drainage tubing, to a patient. [Background technology]

[0002] (Reference to related application) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 299,713, filed January 14, 2022, entitled "Medical Tube Securement Device and Related Products and Methods," the contents of which are incorporated herein by reference for all purposes.

[0003] A medical tube is a tube that is inserted into a patient's body, often through a surgically created opening. The medical tube is left in place for a period of time to provide temporary access to a patient's anatomical region during a medical procedure. A variety of medical tubes and insertion procedures are used to access different anatomical regions and for different purposes. Some medical tubes are inserted to introduce fluids or medical devices into a patient, such as intravenous feeding tubes and catheter tubes. Other medical tubes are inserted to allow the withdrawal of fluids from a patient. Examples of these include medical drainage tubes, such as those used to drain exudates and other fluids from wounds near wounds, often surgical wounds. Still other medical tubes include tracheal tubes, which are inserted into the trachea during a tracheotomy to provide an artificial airway.

[0004] After a medical tube is inserted into a patient, it must be secured to the patient and held in place during the medical procedure. A variety of tube securement techniques have been used for a variety of medical procedures. The challenge in effectively securing the tube is to hold the medical tube in a desired position and orientation for a desired period of time so that the tube cannot move, be inadvertently pushed into the patient, or be pulled out by the patient or medical personnel. Another challenge is to secure the medical tube such that the tube does not detrimentally impede or obstruct access to areas of the patient surrounding the tube that are desired or required at various times for the medical procedure.

[0005] In some medical procedures, medical tubing is often inserted at a relatively small, acute angle relative to the patient's skin at the insertion point, which is common with vascular access tubing, such as intravenous feeding tubes and intravenous catheter tubing.

[0006] In other medical procedures, medical tubes are inserted at a much larger angle to the skin, so that they are often close to or nearly perpendicular to the patient's skin at the insertion point, such as medical drainage tubes and tracheal tubes.

[0007] In many situations, the position and placement of medical tubes remains relatively constant throughout the procedure, and fixation techniques tend to evolve around the consistency of application. For example, a common fixation technique for vascular access procedures is for the tube to be taped to the patient's skin and for the tube to extend from its insertion point approximately parallel to the patient's skin. As another example, the positioning of a tracheal tube is relatively constant, so specialized fixation techniques have been developed to accommodate constant positioning. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] US Patent Application Publication No. 2015 / 0141927 [Patent Document 2] International Publication No. 2002 / 066108 Summary of the Invention [Problem to be solved by the invention]

[0009] Medical drainage tubes, in particular, are difficult to effectively secure because the location and configuration of the medical tubes on a patient varies depending on the type of wound and the location of the wound being drained. A further complicating factor is that such medical drainage tubes may be left in place for extended periods of time, such as weeks, which may include significant time spent at a medical facility while the patient is recuperating at home, where medical personnel can easily attend to any problems that may arise with the drainage tube. A common method of securing medical drainage tubes is to suture the tube. Another method is to tape the tube to the patient's skin. However, to improve drainage tube securement and hold the drainage tube more firmly in place, various medical drainage tube securement devices have been designed. Many of these devices include a retention mechanism that is attached to the patient's skin adjacent to the drainage tube insertion location and engages and holds the tube in a desired location near the location where the drainage tube will exit the patient. Such drainage tube securement devices provide enhanced securement of the drainage tube and protection around the drainage tube compared to simply taping the drainage tube to the patient's skin, but there is a need for a more versatile securement device to enhance performance across a variety of medical tubing applications with different drainage tube applications. [Means for solving the problem]

[0010] A first aspect of the present disclosure is directed to a medical tube securement device for securing a medical tube inserted in a patient. The securement device is versatile for use across a variety of medical tube securement applications, particularly across a wide variety of medical drainage tube applications. The securement device is particularly suited for medical tube securement applications where the medical tube exits the patient at a relatively large angle, such as an angle approaching the patient's adjacent skin surface or at an angle near perpendicular, which is often the case for drainage tube applications, as discussed above. In one conceptualization, such a medical tube securement device comprises a versatile combination of design features adaptable for beneficial use across such a wide variety of medical tube securement applications, particularly for securing medical drainage tubes. The securement device comprises:

[0011] a mounting pad configured to contact the patient's skin to attach the fixation device to the skin, preferably the mounting pad having an adhesive surface for adhering the mounting pad to a surface of the skin; A variable length (variable length) fixation sleeve (fixing sleeve, security sleeve) having a proximal end and a distal end at an opposite longitudinal end from the proximal end, the fixation sleeve being connected to the mounting pad via a connecting structure adjacent the proximal end of the fixation sleeve; a tube passage configured to pass a medical tube for fixation to a patient, the tube passage extending longitudinally through the fixation sleeve; and a fixation sleeve having a securing portion through which the tube passage extends, a cross-sectional passage area of ​​the tube passage at the securing portion perpendicular to a longitudinal path of the tube passage increases as the fixation sleeve shortens and decreases as the fixation sleeve lengthens, the length of the fixation sleeve being adjustable to increase the cross-sectional passage area to receive the medical tube for translation through the tube passage at the securing portion and decrease the cross-sectional passage area to grip the medical tube within the tube passage by the securing portion to secure the medical tube to the fixation device; It is equipped with:

[0012] In the first aspect of the fixation device, the fixation sleeve's fixation portion can be made of any suitable material or structure and structural design to provide the desired variability of the passage cross-sectional area in the tube passage (conduit) of the fixation sleeve with the change in the length of the fixation sleeve. In a preferred embodiment of the fixation sleeve, the fixation portion is made of a woven fabric. The structural materials for intertwining the fibers of such a fabric can include, for example, polymeric and / or metallic materials, with polymeric materials being preferred. Examples of woven structures that can be used for the fixation portion include braided, woven, knotted, crocheted, tatted, felted or bonded (e.g. non-woven) structures, with braided and woven structures generally being more preferred. Any of the above materials constituting the fixation sleeve can be modified to contain and / or release adhesives, nanospheres, nanoparticles or other modifications that facilitate (enhance) the attachment of the fixation sleeve to the medical tube. The materials can also be modified to contain and / or release bioactive substances such as antimicrobials (e.g. those described elsewhere herein in connection with absorbent pads and adhesives), antibiotics or antiseptics.

[0013] As will be appreciated, the medical tube may have a uniform design along the entire length of the medical tube or may have different designs along different longitudinal portions of the medical tube. The medical tube may be constructed of a single piece construction or multiple pieces connected longitudinally. A single piece medical tube may be constructed of one or more longitudinal segments that differ in shape, size, function, and / or material. The medical tube may include or be fluidly connected to a medical device disposed inside the patient (e.g., at the proximal end of the medical tube) and / or may be attached to a medical device disposed outside the patient (e.g., at the distal end of the medical tube). For example, in the case of a drainage tube, the medical drainage tube may include or be fluidly connected to a proximally disposed drain structure that is disposed inside the patient and configured to receive fluid from the patient for discharge through the medical drainage tube. Some types of medical drain devices include a hub (i.e., an area where there is a transition in size, diameter, and / or shape between longitudinal segments of the same tube) adjacent the proximal end of the drainage tube that connects to a proximally located drainage structure already placed in the patient during use. The drainage tube and the drainage structure can be configured with separate portions connected via a hub. Other types of medical drain devices do not have such a hub and are sometimes referred to as "hubless" drains. Such hubless drain devices can be configured, for example, as a single piece that includes both the proximally located drainage structure and a drainage tube portion for conveying collected fluid from the proximally located drainage structure. As will be understood, when referring to features of the fixation sleeve, and more particularly the medical tube that is disposed through (e.g., gripped by) or received in the fixation portion of the fixation sleeve, the reference is only to the features of the fixation sleeve or the portion of the medical tube that is disposed through the fixation portion, as the case may be.Other portions of the medical tube (portions disposed proximally or distally of the fixation sleeve, and possibly the fixation portion) may have different characteristics with different cross-sectional shapes.

[0014] In preferred embodiments of this first aspect, any particular fixation device may be designed to secure medical tubing having a particular outer cross-sectional size (e.g., the outer diameter of a circular tube) or a narrow range of outer cross-sectional sizes. By providing different fixation devices, each designed to receive and hold a different size medical tube, a wide range of medical tubing sizes and configurations may be covered. For example, different fixation device designs may be provided, with fixation sleeves of the different fixation device designs configured to receive and secure a different range of medical tubing diameters. In this manner, fixation devices may be advantageously provided for use in securing a wide range of different sizes of medical tubing. Also, although described herein as primarily securing medical tubing having a circular outer cross-section, it will be appreciated that the fixation portion of the fixation sleeve may be configured to secure tubes having other outer cross-sectional configurations, such as oval or other oval outer cross-sectional shapes.

[0015] A number of reinforcing features may be used in this aspect of the fixation device, either individually or in any combination. In one enhancement, the fixation device can include a bent sleeve holder that can be selectively engaged or disengaged with the fixation sleeve to selectively retain or not retain the fixation sleeve in a bent configuration. Preferably, when the fixation sleeve is retained in a bent configuration, the retained bend of the fixation sleeve comprises at least a longitudinal portion of the fixation sleeve's fixation portion. The ability to retain or not retain the fixation sleeve in a bent configuration provides a significant advantage in that the fixation sleeve can be conveniently manipulated to position and secure the medical tube to the fixation device when the fixation sleeve is not in a bent configuration, while being able to reconfigure or retain the fixation sleeve in a bent configuration after fixation. In the bent configuration, the fixation sleeve and medical tube are advantageously positioned further out of the way. The fixation of the medical tube to the fixation device is advantageously enhanced as a result of the bend, while being less susceptible to inadvertent collisions or other unintended interactions with the patient or medical personnel. In this latter regard, when the retention sleeve having the medical tube secured thereto is in a bent configuration, the bend provides significant additional resistance to the possibility of the medical tube slipping within the retention sleeve as a result of inadvertently pushing the medical tube toward or pulling the medical tube away from the distal end of the retention sleeve, thereby inhibiting distal or proximal movement of the medical tube relative to the retention device. Additionally, bending the medical tube within the retention sleeve provides the benefit of better control over the bending of the medical tube and advantageously reduces the possibility of the medical tube crimping when bent, thereby impeding fluid flow. Such slippage could have the detrimental effect of forcing the drainage tube deeper into the patient than desired. In a preferred embodiment of this enhancement, the bent tube holder is rotatably mounted such that it can be rotated to different radial positions relative to the mounting pad.Thus, allowing for repositioning of the direction in which the secured medical tubing extends away from the fixation sleeve, advantageously allowing for such repositioning of the medical tubing even after the fixation device has been attached to the patient. With such preferred embodiments, the direction in which the medical tubing extends may advantageously be repositioned based on the patient's experience and / or as is convenient for different needs between different stages of a medical procedure.

[0016] In another enhancement, the fixation device can include a compression retainer that can be arranged to hold the fixation sleeve in a compressed configuration under longitudinal compression with the passage cross-sectional area of ​​the tube passage of the fixation portion in an expanded configuration convenient for receiving and translating the medical tube through the tube passage. The compression retainer can be manipulated to release the fixation portion from longitudinal compression by fully disengaging it from the remainder of the fixation device, thereby allowing the fixation sleeve to lengthen to reduce the passage cross-sectional area of ​​the tube passage of the fixation portion to grip the medical tube and thereby secure the medical tube to the fixation device. The fixation sleeve also includes a preferred embodiment of a rotatably mounted bent tube holder, in an enhancement of the rotatably mounted bent tube holder, the bent tube holder is preferably rotatable with respect to an extension portion that extends through a rotating member to which the bent tube holder is attached. The extension member is advantageously configured to engage the compression retainer when the compression retainer is arranged to retain the fixation sleeve in a compressed configuration.

[0017] In another enhancement, the fixation device can include a proximal sleeve coupling structure through which the fixation sleeve is coupled to the mounting pad, where a flared proximal end of the fixation sleeve is sandwiched between a first fixation member and a second fixation member, preferably held in the sandwiched configuration by an adhesive between the first fixation member and the second fixation member. This enhancement advantageously provides a simple structure for coupling the fixation sleeve to the mounting pad, allowing for efficient manufacturing with fewer components to assemble.

[0018] In another enhancement, the fixation device can include a distal collar assembly that holds the distal end of the fixation sleeve. The distal collar assembly manipulates the fixation sleeve to apply or not apply compression to the fixation sleeve to shorten or lengthen it. Additionally, it provides a convenient feature for use to correspondingly increase or decrease the passage cross-sectional area of ​​the tube passage of the fixation portion of the fixation sleeve. In a preferred embodiment of this enhancement where the fixation device also includes a compression retainer enhancement, the distal collar can be advantageously configured to engage the compression retainer when the compression retainer is arranged to hold the fixation sleeve in a compressed configuration.

[0019] In another enhancement, the mounting pad includes an absorbent portion configured to absorb exudate during use of the fixation device, such as blood, serous fluid, or other types of liquids that may seep out of the wound adjacent the insertion location of the medical tube. The absorbent portion is advantageous in keeping the wound area around the inserted medical tube clean and helps prevent such exudate from compromising the integrity of the attachment of the mounting pad to the patient's skin, for example by degradation of the adhesive. In a preferred embodiment of this enhancement, the absorbent portion has an aperture through which the tube passage extends, and advantageously extends completely around the circumference of the medical tube, thereby contributing to the effective absorption of exudate that may seep out of the wound around the circumference of the inserted medical tube.

[0020] A second aspect of the present disclosure is directed to various medical drain fixation products comprising the fixation device of the first aspect. In some preferred embodiments, the products comprise a peelable backing adhered to the adhesive surface of the mounting pad, the peelable backing being configured to be peeled away from the adhesive surface to expose the adhesive surface for adhering the mounting pad to the skin of a patient during use of the fixation device. If the fixation device comprises an absorbent portion, the peelable backing preferably covers the proximal surface of the absorbent portion, the proximal surface being positioned toward the patient when the mounting pad is attached to the patient. The peelable backing can advantageously cover and protect the fluid communication surface of the proximal surface, which can be exposed when the peelable backing is removed. Such a peelable backing can be provided, for example, in a single backing piece or in multiple backing pieces.

[0021] A third aspect of the present disclosure is directed to a kit comprising the fixation device of the first aspect and at least one additional component useful in connection with a medical tube fixation procedure. The fixation device may, for example, be included in the product of the second aspect or not. In some preferred embodiments of the third aspect, the kit comprises a medical tube, which may be a drainage tube or other medical tube, configured for use with the fixation device, e.g., having an outer cross-sectional size and profile that the fixation device is designed to receive and secure. This advantageously reduces the risk of a medical practitioner attempting to secure a medical tube outside of the design parameters for which the fixation device is designed to be used.

[0022] A fourth aspect of the disclosure is directed to a method of securing a medical tube to a patient with a retention device, the retention device having a variable length retention sleeve and a tube passageway therethrough to receive a medical tube for retention, the retention sleeve including a retention portion where a passageway cross-sectional area, the cross-sectional area of ​​the tube passageway perpendicular to a longitudinal path of the tube passageway, increases as the retention sleeve shortens and decreases as the retention sleeve lengthens, the retention sleeve length being adjustable to increase the passageway cross-sectional area to receive the medical tube for translation through the tube passageway and decrease the passageway cross-sectional area to grip the medical tube within the tube passageway at the retention portion to secure the medical tube to the retention device. The method includes:

[0023] The medical tube in the tube passage is gripped (grip with securing portion) by the securing portion of the securing sleeve while the medical tube extends through the tube passage into the patient's body. In some preferred embodiments, the securing device is according to the first aspect, and is optionally provided in the securing product of the second aspect and the kit of the third aspect. The securing device of the first aspect can advantageously provide great flexibility for the performance of various operations during a medical procedure.

[0024] A fifth aspect of the present disclosure is directed to a method for manufacturing the fastening device of the first aspect. The combination of applicable designs of the fastening device can provide significant operational capabilities for using the fastening device with a relatively small number of preassembled components. Advantageously, this allows for a relatively simple manufacturing operation for producing the fastening device of the first aspect. The method can also include the step of providing the fastening device product of the second aspect by applying a releasable backing to the fastening device.

[0025] Numerous feature refinements and additional features may be used individually or in any combination within the scope of the subject matter of the aspects of the present disclosure. Thus, each of the features described in the following description, as set forth in the numbered example combinations and claims appended hereto, and / or illustrated in the drawings, may, but need not, be used together with any other feature or feature combination of any of the aspects of the present disclosure. [Brief description of the drawings]

[0026] [Figure 1] 1 is a perspective view of an exemplary embodiment of a medical tube fixation device. [Diagram 2] 2 is a perspective view of the medical tube securement device of FIG. 1 attached to a patient's skin with a medical tube secured to the medical tube securement device. [Diagram 3] 2 is a partial side view showing a portion of a securing portion of the securing sleeve of the medical tube securing device of FIG 1, the securing portion being in a relaxed state. [Figure 4] FIG. 4 is a cross-sectional view of a portion of the fixing portion shown in FIG. 3 . [Diagram 5] 4 is a partial side view of the fixture shown in Figure 3, the fixture in a compressed state prior to a medical tube being received therethrough and secured to the medical tube securement device of Figure 1; [Figure 6] 6 is a cross-sectional view of the fastener of FIG. 5 receiving a medical tube; [Figure 7] 5 is a partial side view of a portion of the fixture shown in FIG 3 with the fixture relaxed from the compressed state of FIG 5 to grip a medical tube received through the fixture. [Figure 8] 8 is a cross-sectional view of a portion of the fixing portion shown in FIG. 7 that grips the medical tube. [Figure 9] 2 is a perspective view of the medical tube retention device of FIG. 1 , showing the medical tube secured within the retention sleeve and the retention sleeve configured in a bent configuration (folded shape) and worn against the skin of a patient. [Figure 10] 2 is a perspective view of the medical tube retention device of FIG. 1 shown worn against a patient's skin with the medical tube secured within the retention sleeve and the retention sleeve held in a bent configuration; [Figure 11] 2 is a perspective view of the medical tube retainment device of FIG. 1 worn against a patient's skin with the medical tube retained within the retaining sleeve, illustrating features of the rotation lock structure. [Figure 12] 2 is a perspective view of a portion of the medical tube securement device of FIG. 1 including a rotating member and a bent tube holder supported on the rotating member. [Figure 13] 2 is a perspective view of the medical tube securement device of FIG. 1 showing an example of radial positioning of a bent sleeve holder. [Figure 14] 2 is a perspective view of the medical tube securement device of FIG. 1 illustrating another example of radial positioning of the bent sleeve holder. [Figure 15] 10 is a perspective view of the medical tube securement device of FIG. 1 illustrating yet another example of radial positioning of the bent sleeve holder. [Figure 16]2 is a perspective view of the medical tube securement device of FIG. 1 showing an absorbent portion of the mounting pad. [Figure 17] 13 is a perspective view showing an alternative configuration of the absorber portion of the mounting pad. [Figure 18] 2 is a perspective view of a variation of the medical tube fixation device of FIG. 1 including a compression retainer, with the medical tube received through the fixation sleeve and shown worn against the skin of a patient. [Figure 19] 19 is a perspective view of a variation of the medical tube securement device of FIG. 18. [Figure 20] FIG. 19 is a perspective view of the variation of the medical tube retention device of FIG. 18 after removal of the compression retainer to grip the medical tube within the retention sleeve, with the medical tube retention device shown attached to a patient's skin and with the medical tube received through the retention sleeve. [Figure 21] FIG. 1 illustrates the relative positions of several components for manufacturing an exemplary medical tube fixation device. [Figure 22] 13A-13C show an example of flaring the proximal end of the fixation sleeve during manufacturing of the medical tube fixation device. [Diagram 23] 13A-13C illustrate examples of bonding a fixation sleeve to a mounting pad structural sheet during manufacturing of an exemplary medical tube fixation device. [Figure 24] 13A-13C further illustrate examples of bonding a fastening sleeve to a mounting pad structural sheet during manufacturing of an embodiment. [Diagram 25] 1 is a cross-sectional view showing an example of a first preliminary product form during manufacture of a medical tube fixing device. FIG. [Figure 26] FIG. 26 is a perspective view of the first preliminary product form shown in FIG. 25. [Figure 27] 27 illustrates the addition of a bent tube holder having a rotatable mount on the first pre-product form of FIGS. 25 and 26 during manufacture of the medical tube fixation device. [Figure 28] 27 further illustrates the addition of a bent tube holder onto the first pre-product form of FIGS. 25 and 26 during manufacture of the exemplary medical tube securement device. [Figure 29] 1 is a perspective view of an example of a second pre-product form during manufacturing of an exemplary medical tube securement device. [Diagram 30] 30 illustrates the assembly of additional components according to the second pre-product form of FIG. 29 during manufacture of the exemplary medical tube fixation device. [Diagram 31] 30 further illustrates the assembly of additional components according to the second pre-product form of FIG. 29 during manufacture of the exemplary medical tube securement device. [Diagram 32] 30 further illustrates the assembly of additional components with the second pre-product form of FIG. 29 during manufacture of the exemplary medical tube securement device. [Diagram 33] 13 is a perspective view of a third pre-product form during manufacturing of an exemplary medical tube securement device. FIG. [Diagram 34] 34 illustrates the assembly of the third pre-product form of FIG. 33 with additional components to provide an exemplary medical tube retainment device product comprising an exemplary medical tube retainment device. [Diagram 35] 1 is an illustration of an exemplary kit including a medical tube securement device and one or more additional components. [Diagram 36] 1 is a perspective view of an exemplary embodiment of a medical tube fixation device. [Figure 37] FIG. 37 is a perspective view of the medical tube fixation device of FIG. 36, showing the fixation sleeve held in a bent configuration by a bent tube holder. [Figure 38] 37 is another perspective view of the medical tube fixation device of FIG. 36, showing the fixation sleeve held in a bent configuration by a bent tube holder. [Figure 39] 1 is a perspective view of another exemplary embodiment of a medical tube securement device. [Diagram 40] 40 is a perspective view of a rotating member and a bent sleeve holder of the medical tube securement device of FIG. 39 . [Diagram 41] 40 is a perspective view of the medical tube securement device of FIG. 39 securing the medical tube in a bent configuration and showing the rotating members set in exemplary radial positions. [Diagram 42]41 is a perspective view of the medical tube securement device of FIG. 39 shown securing the medical tube in a bent configuration and with the rotating members set to a different exemplary radial position than that shown in FIG. 40. [Diagram 43] 40A-40D illustrate stages of assembly of the distal collar of the medical tube fixation device during manufacture of the medical tube fixation device of FIG. 39. [Diagram 44] 40A-40D illustrate different stages of assembly of the distal collar of the medical tube fixation device during manufacture of the medical tube fixation device of FIG. 39. [Diagram 45] 40A-40D illustrate different stages of assembly of the distal collar of the medical tube fixation device during manufacture of the medical tube fixation device of FIG. 39. [Figure 46] 40A-40D illustrate different stages of assembly of the distal collar of the medical tube fixation device during manufacture of the medical tube fixation device of FIG. 39. [Figure 47] 40A-40D illustrate different stages of assembly of the distal collar of the medical tube fixation device during manufacture of the medical tube fixation device of FIG. 39. [Figure 48] 40A-40D illustrate different stages of assembly of the distal collar of the medical tube fixation device during manufacture of the medical tube fixation device of FIG. 39. [Figure 49] 2 is a partial cross-sectional view of the assembled medical tube fixation device of FIG. 1 showing features of the assembled distal collar that retains the distal end of the fixation sleeve. [Figure 50] 40 is a perspective view of a variation of the medical tube retaining device of FIG. 39 including a compression retainer, showing the medical tube received through the retaining sleeve in a compressed state. [Figure 51] FIG. 51 is a perspective view of the variation of the medical tube retention device of FIG. 50 after the compression retainer has been removed to grip the medical tube within the retention sleeve, with the medical tube being received through and gripped by the retention sleeve after being released from compression. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] FIG. 1 illustrates an exemplary embodiment of a fixation device 100 for securing a medical tube inserted in a patient. As shown in FIG. 1, the fixation device 100 includes a mounting pad 102 configured to interface with a surface of a patient's skin to attach the fixation device 100 to the skin. The mounting pad 102 is preferably made of a material that is sufficiently flexible to conform to the topography of the patient's skin. The mounting pad 102 includes a distal side 104 that faces away from the patient's skin during use, and a proximal side (not shown) opposite the distal side 104. The proximal side of the mounting pad 102 faces the skin for attachment to the patient, and is configured to contact the skin. As used herein, "proximal" refers to a relative positioning toward the patient's skin during use of the fixation device 100. "Distal" refers to a positioning away from the patient's skin during use of the fixation device 100. In a preferred embodiment, mounting pad 102 includes an adhesive layer having an exposed adhesive surface on a proximal surface of mounting pad 102 through which mounting pad 102 may be adhered to a patient's skin during use. Although not preferred, mounting pad 102 may be attached to the patient's skin or attachment to the skin may be assisted by other fastening means, for example, by taping mounting pad 102 to the skin with tape extending across distal surface 104 of mounting pad 102 and tape adhered to the skin beyond the perimeter of mounting pad 102, or by the use of sutures.

[0028] The fixation device 100 includes a fixation sleeve 106 coupled to the mounting pad 102 adjacent the proximal end of the fixation sleeve 106. In the exemplary embodiment of the fixation device 100 shown in FIG. 1, the coupling structure by which the fixation sleeve 106 is coupled to the mounting pad 102 includes a flared proximal end of the fixation sleeve 106. The flared proximal end is disposed between and adhered to a first surface of the distal face 104 of the mounting pad 102 and an opposing second surface of the proximal face of the base member 108. In this embodiment, the coupling structure includes an adhesive that bonds and is disposed between the opposing surfaces of the mounting pad 102 and the base member 108, and an intermediate flared proximal end of the fixation sleeve 106 sandwiched between the opposing surfaces of the mounting pad 102 and the base member 108. The distal end of fixation sleeve 106 is coupled to and retained by distal collar 110 .

[0029] The fixation device 100 also includes a rotating member 112. The rotating member 112 engages an extension portion 114 of the base member 108 that protrudes through an aperture in the rotating member 112 and is rotatably retained within a circular groove track that extends around the outer periphery of the extension portion 114 of the base member 108.

[0030] The fixation device 100 includes a tube passage 116 extending longitudinally through the distal collar 110, the fixation sleeve 106, the base member 108, and the mounting pad 102. The tube passage 116 has a proximal end that is open to the proximal surface of the mounting pad 102 and a distal end that is open to the distal end of the distal collar 110. As shown in FIGURE 1, the tube passage 116 has a longitudinal axis 118 that extends longitudinally of the tube passage between the proximal end of the tube passage 116 and the distal end of the tube passage 116.

[0031] The fixation sleeve 106 includes a fixation portion 122 at which the medical tubing 120 extending through the tube passage 116 can be grasped by the fixation sleeve 106 to secure the medical tubing 120 to the fixation device 100 during use. During use, the fixation device 100 is attached to the skin of a patient, the medical tubing 120 can be placed into the patient's body through the tube passage 116, and once at a desired position within the patient, the medical tubing 120 is secured to the fixation device 100 by the fixation portion 122 of the fixation sleeve 106. Thus, the medical tubing 120 can be held in a constant position relative to the fixation device 100 and the patient to which the fixation device 100 is attached.

[0032] 2 illustrates the use of fixation device 100 attached to a patient's skin 124 with medical tubing 120 extending through tube passage 116 and with proximal end 126 of medical tubing 120 already positioned at a desired location within the patient. Medical tubing 120 is secured to fixation device 100 and held in place by fixation sleeve 106 gripping medical tubing 120 within tube passage 116 in fixation portion 122.

[0033] 1 and 2, unlike the proximal end of fixation sleeve 106 which is in a fixed position relative to base member 108 and mounting pad 102, the distal end of fixation sleeve 106 is not in a fixed position relative to base member 108 and mounting pad 102. Because fixation sleeve 106 is a flexible structure, the position of the distal end of fixation sleeve 106 relative to base member 108 and mounting pad 102 can be changed by, for example, bending fixation sleeve 106 intermediately between base member 108 and distal collar 110. As will be appreciated, when fixation sleeve 106 is bent, tube passage 116 therethrough and longitudinal axis 118 of tube passage 116 are also bent within the bent portion of fixation sleeve 106. Also, as shown in FIG. 2, when fixation sleeve 106 is bent, medical tubing 120 is bent within the bent portion of fixation sleeve 106 as medical tubing 120 is disposed through tube passage 116.

[0034] The fixation sleeve 106 of the fixation device 100 illustrated in Figures 1 and 2 has a variable length characteristic such that the longitudinal length of the fixation sleeve 106 between the proximal and distal ends of the fixation sleeve 106 varies depending on whether and to what extent the fixation sleeve 106 is subjected to a longitudinally applied force. For example, the fixation sleeve 106 can be subjected to a longitudinally applied compressive force by pushing the distal collar 110 towards the base member 108 and the mounting pad 102, thereby shortening the length of the fixation sleeve 106. The fixation sleeve 106 can also be subjected to a longitudinally applied tensile force by pulling the distal collar 110 away from the base member 108 and the mounting pad 102, thereby lengthening the length of the fixation sleeve 106. The magnitude of such longitudinally applied force affects the amount by which the fixation sleeve 106 decreases in length in the case of a longitudinally applied compressive force, and the amount by which the fixation sleeve 106 increases in length in the case of a longitudinally applied tensile force.

[0035] The fixation portion 122 is a longitudinal portion of the fixation sleeve 106 that lengthens or shortens with changes in the longitudinal force experienced by the fixation sleeve 106 and the corresponding changes in the force experienced by the fixation portion 122. The cross-sectional area of ​​the tube passage 116 perpendicular to the longitudinal path of the tube passage along the longitudinal axis 118 increases as the fixation sleeve 106 shortens, whereas the cross-sectional area decreases as the fixation sleeve 106 lengthens. As will be appreciated, when the fixation sleeve 106 shortens due to longitudinal compression, the length of the fixation portion 122 correspondingly shortens as the fixation sleeve 106 shortens, thereby increasing the cross-sectional area of ​​the tube passage 116. Thus, a medical tube 120 having an outer cross-section small enough to fit through the enlarged cross-sectional area of ​​the tube passage 116 may be inserted through the tube passage 116 in the fixation portion 122. If the outer cross-section of medical tube 120 has a maximum cross-sectional dimension (e.g., the outer diameter of a circular tube cross-section) that is greater than the corresponding maximum cross-sectional dimension of tube passage 116 when retention sleeve 106 is in a relaxed state (i.e., a state in which there is no longitudinal compression or tension applied), then when the longitudinal compression applied to medical tube 120 positioned through tube passage 116 is released, the inner wall surface of retention portion 122 grips medical tube 120 within the tube passage, thereby securing medical tube 120 to retention sleeve 106.

[0036] The fixation portion 122 of the fixation sleeve 106 represents a longitudinal portion of the fixation sleeve 106 that can change the cross-sectional passage area of ​​the tube passage 116 by shortening the length of the fixation sleeve 106 to increase the cross-sectional passage area of ​​the tube passage 116 to allow insertion of the medical tube 120, and then increase the length of the fixation sleeve 106 to decrease the cross-sectional passage area of ​​the tube passage to grip and hold the medical tube 120. As will be appreciated, the fixation portion 122 may comprise various longitudinal portions of the fixation sleeve 106 depending on the material of construction, the shape of the construction, and the particular configuration of the fixation sleeve 106 that includes the coupling structure with which the proximal and distal ends of the fixation sleeve 106 are engaged. For example, the portion of the fixation sleeve 106 proximate the coupling structure may be prevented from contracting in cross-section sufficiently to grip the medical tube 120 disposed through the tube passage 116 by engagement with the coupling structure. Similarly, the longitudinal length of such end portions unavailable for gripping medical tube 120 may depend on the particular size (e.g., outer diameter) of medical tube 120 to be gripped within fixation sleeve 106. It will also be appreciated that fixation portion 122 may not have a uniformly sized cross-sectional area of ​​tube passage 116 at all longitudinal points within fixation portion 122. For example, when fixation sleeve 106 is in a longitudinally compressed state, the passage cross-sectional area of ​​tube passage 116 may be somewhat larger or bulging near the longitudinal midpoint of fixation portion 122 relative to tube passage 116 closer to the proximal and distal ends of fixation portion 122, where the passage cross-sectional area of ​​tube passage 116 may be more affected by the coupling structure with which fixation sleeve 106 engages. Similarly, when the fixation sleeve 106 is under longitudinal tension, the passage cross-sectional area of ​​the tube passage 116 may be somewhat smaller near the longitudinal midpoint of the fixation portion 122 than near the proximal and distal ends of the fixation portion 122, where the passage cross-sectional area of ​​the tube passage 116 may be more affected by the coupling structure with which the fixation sleeve 106 engages.As a result of possible variations in the passage cross-sectional area of ​​tube passage 116 through fixture 122, when in the enlarged cross-sectional compressed state, tube passage 116 may have a minimum passage cross-sectional area at one or more longitudinal points of fixture 122 that define a minimum insertion cross-section for receiving medical tube 120 inserted through fixture 122. In some embodiments, with fixture 122 in a compressed state to receive insertion of medical tube 120, the minimum insertion cross-section may be defined by the passage cross-sectional area of ​​tube passage 116 adjacent the proximal and / or distal coupling structures.

[0037] Reference will now be made to Figures 3-8 in conjunction with Figures 1-2 to further describe the features of the fixation portion 122 of the fixation sleeve 106 of the fixation device 100 illustrated in Figures 1 and 2. Figures 3, 5, and 7 each show a longitudinal portion of the fixation portion 122, but in different configurations having different sizes for the cross-sectional passage area of ​​the tube passage 116 through the fixation portion 122. Figures 4, 6, and 8 are corresponding cross-sectional views of the fixation portion 122 illustrated in Figures 3, 5, and 7, respectively, taken transversely to the longitudinal direction of the tube passage 116. Figures 3, 5, and 7 illustrate the difference in the cross-sectional passage area of ​​the tube passage 116 in the different illustrated configurations. 3 and 4 show the fixation portion 122 alone in a relaxed state with no longitudinal force applied, in which the cross-sectional passage area of ​​the tube passage 116 is too small to accommodate the medical tube 120 of the size that the fixation portion 122 is designed to secure to the fixation device 100. FIGS. 5 and 6 show the fixation portion 122 in a compressed state where the fixation portion 122 is subjected to a longitudinally applied compressive force, as illustrated by the arrows shown in FIG. 5. In the compressed state of FIGS. 5 and 6, the cross-sectional passage area of ​​the tube passage 116 is enlarged relative to the relaxed state shown in FIGS. 3 and 4. FIGS. 5 and 6 show the medical tube 120 received through the tube passage 116 at the fixation portion 122, illustrating that in this compressed state, the outer cross-sectional area of ​​the medical tube 120 is smaller than the cross-sectional passage area of ​​the tube passage 116. 7 and 8 next show medical tube 120 positioned through tube passage 116 after the longitudinal compression of Figures 5 and 6 has been released and fasteners 122 have relaxed sufficiently to allow medical tube 120 to be gripped within tube passage 116 to secure medical tube 120 to fastener device 100. As will be appreciated, medical tube 120 shown in Figures 7 and 8 can be released from grip by fasteners 122 to allow medical tube 120 to be repositioned relative to fasteners 122 or removed entirely from fasteners 122.In this manner, the medical tube 120 that has been inserted into the patient and retained by the fixation device 100 can be repositioned within the patient or removed and replaced with another medical tube 120. The new or repositioned medical tube 120 can then be secured to the fixation device 100 by again releasing the longitudinally applied compression of the fixation portion 122 to allow the fixation sleeve 106 to relax and grip the new or repositioned medical tube 120. In other circumstances, after the medical tube 120 has been released, the fixation device 100 can be removed from the patient without removing the medical tube 120 from the patient, and a new fixation device 100 can then be attached to the patient, for example, if the attachment of the previous fixation device 100 to the patient is compromised or for wound cleaning and / or wound dressing changes. In still other situations, both the medical tube 120 and the retention device 100 may be replaced with a new medical tube 120 and a new retention device 100 .

[0038] Reference is now made primarily to Figures 9 and 10 in conjunction with Figures 1-8. Figures 9 and 10 show the fixation device 100 of Figure 1 in use attached to a patient's skin 124 and with the medical tube 120 disposed within the patient through the fixation sleeve 106. The fixation device 100 includes a bent sleeve holder 130 which, in the illustrated embodiment of the fixation device 100, includes a retention channel 132 configured to selectively receive and retain a longitudinal portion of the fixation sleeve 106 to retain the fixation sleeve 106 in a bent configuration with the distal portion of the fixation sleeve 106 biased toward the skin 124 and toward the mounting surface of the mounting pad 102. As used herein, the mounting surface of the mounting pad 102 refers to a plane perpendicular to the longitudinal axis 118 of the tube passage 116 at the point where the tube passage 116 opens at the proximal surface of the mounting pad 102. The bent sleeve holder 130 includes flexible tabs 134a, 134b that are sufficiently flexible to allow the fixation sleeve 106 to be forced into the retaining channel 132, with the flexible tabs 134a, 134b momentarily deflecting laterally as the fixation sleeve 106 is forced into the retaining channel 132. FIG. 9 illustrates the fixation sleeve 106 being forced into the retaining channel 132 with the flexible tabs 134a, 134b deflecting laterally as the fixation sleeve 106 is forced into the retaining channel 132. However, the flexible tabs 134a, 134b should be sufficiently rigid to retain the receiving portion of the fixation sleeve 106 within the retaining channel 132 to hold the fixation sleeve 106 in a bent configuration, as shown in FIG. 10 , in the bent configuration, the fixation sleeve 106 has a bend 136 through a portion of the fixation sleeve 106 between the proximal end of the fixation sleeve 106 and the retention channel 132. In the bent configuration, a distal portion of the bend 136 of the fixation sleeve 106 is biased toward the skin 124 and the mounting surface of the mounting pad 102, such that the standoff of the fixation sleeve 106 from the mounting pad 102 and the surrounding skin 124 of the patient is relatively small.The fixation sleeve 106 can be released from the bent configuration by pulling the fixation sleeve 106 out of the retaining channel 132 with the flexible tabs 134a, 134b temporarily deflected as the fixation sleeve 106 is removed from the retaining channel 132. As shown in FIG. 10, in the bent configuration, the fixation sleeve 106 is bent at an angle of approximately 90°, but it will be understood that the bent sleeve holder 130 can be configured to hold the fixation sleeve 106 bent at an angle greater than or less than 90°. The flexible tabs 134a, 134b can be made of any material of construction, such as metal or polymeric material, and preferably made of a polymeric material (more preferably a thermoplastic elastomer), to provide both a flexibility that allows the fixation sleeve 106 to be removed from the retaining channel 132 by being pushed into the retaining channel 132 by elastic deformation, and a desired level of retention of the fixation sleeve 106 in the bent configuration when the receiving portion of the fixation sleeve 106 is received within the retaining (receiving) channel 132. The configuration shown in Figures 9 and 10 illustrates one preferred embodiment in which the bent sleeve holder 130 receives and holds a longitudinal portion of the fixed portion 122 of the fixed sleeve 106, and the bent portion 136 also comprises a longitudinal portion of the fixed portion 122.

[0039] One advantage of fixation device 100 configured to selectively retain fixation sleeve 106 in a bent configuration, as shown in FIG. 10 , is that medical tube 120 can be positioned as desired within a patient and then secured to fixation device 100 while being gripped by fixation portion 122 of fixation sleeve 106. In this manner, medical tube 120 can be conveniently positioned and held in a bent configuration in relatively close proximity to the patient, greatly reducing the risk of accidental or unintended interaction with fixation sleeve 106 or medical tube 120 by the patient or medical personnel. Additionally, this design provides advantageous flexibility to easily release fixation sleeve 106 from the bent configuration to allow repositioning of medical tube 120 as well as to allow removal of medical tube 120 from the patient or to allow removal and replacement of fixation device 100 without repositioning or removal of medical tube 120, or to allow manipulation of fixation sleeve 106 to remove medical tube 120. Another advantage is that in the bent configuration, bend 136 provides additional resistance to release of fixation portion 122 from gripping medical tube 120 if a patient or medical practitioner intentionally or inadvertently pushes distal collar 110, which may impart longitudinally applied compression to fixation sleeve 106 and otherwise lead to undesired release of fixation of medical tube 120 by fixation sleeve 106 and undesired movement of medical tube 120. Bend 136 helps prevent undesired release of fixation of medical tube 120 by fixation sleeve 106. Additionally, the structure defining retention channel 132 provides some resistance to expansion of the cross-section of fixation sleeve 106 within retention channel 132 to allow for an expansion of the passage cross-sectional area of ​​tube passage 116 within fixation portion 122 to release medical tube 120. The bent configuration also advantageously provides additional resistance to someone pushing the medical tube 120 towards the distal collar 110 with enough force to overcome the force with which the medical tube 120 is held by the fixation sleeve 106, or pulling the medical tube 120 away from the distal collar 110.As can be seen from the view of FIG. 10, when someone, such as a patient, pushes medical tube 120 towards distal collar 110 or pulls medical tube 120 away from distal collar 110, bend 136 provides additional resistance to movement of medical tube 120 through fixation sleeve 106.

[0040] Reference will now be made to Figures 11-15 in conjunction with Figures 1-10 in connection with a description of the rotational features of the fixation device 100 that allow the bent sleeve holder 130 to be rotated and thereby positioned at various radial positions relative to the mounting pad 102. In the exemplary fixation device 100 shown in Figures 1 and 2, the bent sleeve holder 130 is mounted to a rotating member 112 that is selectively rotatable relative to the base member 108, thereby allowing the bent sleeve holder 130 to be positioned at different radial positions relative to the mounting pad 102. More specifically, the rotating member 112 has an opening 140 (best seen in Figure 12) through which the extension portion 114 of the base member 108 extends. The rotating member 112 is received and rotatably held in a circular groove track extending around the periphery of the extension portion 114, which serves as an axle about which the rotating member 112 can rotate to radially position the bent sleeve holder 130. As will be appreciated, in the exemplary configuration of the fixation device 100, the longitudinal axis 118 of the tube passage 116 through the mounting pad 102 is coaxial with the opening through the extension portion 114 about which the rotating member 112 rotates, so that the different radial positions at which the bent sleeve holder 130 may be positioned are radially spaced apart relative to the longitudinal axis 118 of the tube passage 116 through the mounting pad 102.

[0041] The fixation device 100 includes a radial positioning lock for selectively locking the curved sleeve holder 130 at different radial positions. The rotating member 112 and the base member 108 have complementary interlocking structures that are engageable to selectively lock the radial position of the rotating member 112 at different radial positions. In the illustrated embodiment of the fixation device 100, the base member 108 includes a plurality of recesses 142 radially spaced about the base member 108. The rotating member 112 includes a plurality of protrusions 144 that are configured to be receivable in the recesses 142 to lock the rotating member 112 in a fixed radial position relative to the base member 108. As shown in FIG. 11 , the rotating member 112 is made of a material having suitable flexibility to allow the rotating member 112 to rotate relative to the base member 108, as indicated by the rotation arrow in FIG. 11 , by elastically deforming a portion of the rotating member 112 to disengage the protrusion 144 from the recess 142. After rotating the rotating member 112 to a desired radial position, the rotating member 112 can be locked in that radial position by manipulating the elastically deformable portion of the rotating member 112 to engage the protrusion 144 with a corresponding one of the recess 142. An operating tab 146 on the rotating member 112 can be used by a person to manipulate the elastically deformable portion of the rotating member 112 to engage and disengage the protrusion 144 with the recess 142, rotate the rotating member 112 relative to the base member 108, and then engage the protrusion 144 with a corresponding one of the recess 142 at a new radial position. Preferably, the recess 142 continues around the complete circumference of the rotating member 112, and the rotating member 112 and bent sleeve holder 130 are rotatable a full 360° about the longitudinal axis 118 as a rotational axis to allow the rotating member 112 and bent sleeve holder 130 to be positioned at various radial positions about the rotational axis. Figures 13-15 show the rotating member 112 and bent sleeve holder 130 positioned at three different exemplary radial positions relative to the mounting pad 102.

[0042] In enhanced embodiments, the rotating member 112 and the bent sleeve holder 130 may be provided as a single piece of construction, preferably a single homogenous material of construction, typically a single molded article (e.g., a single injection molded article) made of a polymeric material, having suitable properties to provide the desired characteristics for the functions of both the flexible tabs 134a, 134b and the elastically deformable portions of the rotating member 112. In some preferred embodiments, such materials of construction for the rotating member 112 and the bent sleeve holder 130 have a hardness in the range of 60 to 90 Shore A durometer.

[0043] An important advantage in the flexible utility of the fixation device 100 is provided by the configuration that allows the bent sleeve holder 130 to be positioned at different radial positions relative to the mounting pad. Regardless of the position of the bent sleeve holder 130 in the direction in which the medical tube 120 protrudes from the bent sleeve holder 130, the mounting pad can be positioned relative to the patient for optimal attachment of the fixation device 100 to the patient. The bent sleeve holder 130 can be positioned in the most advantageous radial position relative to the patient's body regardless of the orientation of the mounting pad 102, for example, to avoid unintended patient or medical personnel interaction with the medical tube 120 or fixation sleeve 106, or to maintain the position of the fixation sleeve 106 and medical tube 120 to avoid obstruction of areas on the patient where medical access may be desired while the medical tube (drainage tube) 120 is being secured to the fixation device 100. Furthermore, the radial positions of the bent sleeve holder 130 and the medical tube 120 can be adjusted as desired based on the patient's experience or changing medical access needs. As will be appreciated, if bent sleeve holder 130 is radially repositioned while medical tube 120 is retained within retaining channel 132, the radial movement will tend to impart torsional stresses to fixation sleeve 106 and to the medical tube 120 gripped by fixation sleeve 106. Thus, prior to changing the radial position of bent sleeve holder 106, it is preferable to remove fixation sleeve 106 from retaining channel 132 so that bent sleeve holder 106 can be radially repositioned without imparting such torsional stresses to fixation sleeve 106 or medical tube 120.

[0044] Reference is now made to FIG. 16 in conjunction with FIGS. 1-15 in connection with a description of the absorbent function of the fixation device 100 for absorbing exudate from a patient during use. As shown in FIG. 16, the mounting pad 102 of the exemplary fixation device 100 includes an absorbent portion in the form of an absorbent pad 150 exposed on a proximal surface 152 of the mounting pad 102 to provide an absorbent capacity for absorbing exudate from a patient's wound through which the secured medical tube 120 extends during use of the fixation device 100. In the example shown in FIG. 16, the absorbent pad 150 is attached to a structural sheet 154 of the mounting pad 102 by adhesive or the like. The absorbent pad 150 contacts the patient's skin during use of the fixation device 100 and has a proximal surface 156 configured to contact the skin. The absorbent pad 150 includes an opening 158 that forms a portion of the tube passageway 116. The opening of aperture 158 in proximal surface 156 of absorbent pad 150 provides the proximal opening of tube passageway 116 in the exemplary embodiment of fixation device 100 shown in FIGS. 1-16. In an alternative variation, fixation device 100 may be without absorbent pad 150, in which case the opening in structural sheet 154 would provide the proximal opening of tube passageway 116. Structural sheet 154 may be made of any suitable material that provides the desired structural integrity to mounting pad 102 and is suitably flexible to conform to the topography of the patient's skin to which mounting pad 102 is attached. As will be appreciated, it may be desirable to remove fixation device 100 from the patient without removing medical tube 120 from the patient, and then replace the removed fixation device 100 with a new fixation device 100, for example, a new fixation device 100 with a new absorbent pad 150. Examples of structural materials for the structural sheet include flexible plastic and fabric materials.

[0045] 16 also illustrates the longitudinal axis 118 of the tube passageway 116, which for the portion of the tube passageway 116 that extends through the mounting pad 102, is substantially perpendicular to the proximal surface of the proximal surface 152 of the mounting pad 102 adjacent where the proximal end of the tube passageway 116 opens at the proximal surface 152 of the mounting pad 102. In the illustrated embodiment of the fixation device 100, the proximal end of the tube passageway 116 opens through the proximal surface 156 of the absorbent pad 150 and is perpendicular to the proximal surface 156 of the absorbent pad 150. It will be appreciated that longitudinal axis 118 may curve through fixation sleeve 106 if fixation sleeve 106 is bent as illustrated in any of Figures 9-15, but longitudinal axis 118 will typically be substantially straight for the portion of tube passageway 116 that passes through mounting pad 102, even when fixation sleeve 106 is bent distal to mounting pad 102, as illustrated in Figures 9-15. It will also be appreciated that the medical tubing (e.g., medical tubing 120) exiting the patient's body typically enters the proximal end of tube passageway 116 substantially perpendicular to the patient's skin in the vicinity thereof.

[0046] The inclusion of absorbent pad 150 in the exemplary embodiment of the fixation device 100 advantageously allows for the absorption of exudate migrating from the patient's wound into which the medical tube 120 has been inserted. Such absorption of exudate advantageously helps maintain a clean wound area and helps inhibit exudate from seeping between the structural sheet 154 and the patient's skin, loosening the adhesive bond between the mounting pad 102 and the patient's skin. The mounting pad 102 can be made of an absorbent material and have a desired absorption capacity, for example, as disclosed elsewhere herein. The absorbent pad 150 can be beneficially provided with an antimicrobial agent. Examples of some possible antimicrobial agents for use in the absorbent portion of the mounting pad 102 or elsewhere in connection with the fixation device or a product or kit including the fixation device include polymyxin, bacitracin, mupirocin, silver, chlorhexidine gluconate and similar derivatives, or iodine and its derivatives. More generally, the mounting pad 102 can include an antimicrobial agent, which can include, for example, any of the exemplary microbial agents described for the absorbent pad. Such antimicrobial agents may be included in the absorbent pad, the adhesive layer, and / or other layers or features of the mounting pad 102. Preferably, if the mounting pad 102 is provided with an antimicrobial agent, the antimicrobial agent is included in one or more portions of the mounting pad 102 that are open to fluid communication with the patient (e.g., the patient's skin or wound) so that the antimicrobial agent can contact or be released to the patient (e.g., so that the antimicrobial agent can contact the patient's skin or wound).

[0047] In an embodiment of the fixation device 100 as shown in FIG. 16, the proximal surface of the structural sheet 154 completely surrounds the periphery of the absorbent pad 150. In some preferred embodiments of the fixation device 100, the proximal surface 152 of the mounting pad 102 includes an adhesive layer covering that portion of the proximal surface of the structural sheet 154 that surrounds the periphery of the absorbent pad 150. Such an adhesive layer is thus exposed on the proximal surface 152 of the mounting pad 102 and can be advantageously used to adhere the mounting pad 102 to the patient's skin completely around the periphery of the absorbent pad 150. The absorbent pad 150 may or may not include an adhesive on the proximal surface 156. In some preferred embodiments, the proximal surface 156 of the absorbent pad 150 is substantially free of adhesive that may otherwise impede effective absorption of exudate from an adjacent wound. However, in some alternative embodiments, the mounting pad 102 may include an adhesive on at least a portion of the proximal surface 156 to adhere the absorbent pad 150 to the patient's skin. However, in such alternative embodiments, the adhesive preferably does not cover the entire proximal surface 156, and portions of the proximal surface 156 are not covered by the adhesive to provide better fluid communication at locations not covered by the adhesive for exudates to penetrate the absorbent material of the absorbent pad 150. For example, such adhesive on the proximal surface 156 may be a perforated (perforated) layer of adhesive, with the perforated areas forming part of the proximal surface 156 being uncovered by the adhesive. FIG. 17 illustrates a variation of an absorbent pad 150' having a perforated layer of adhesive disposed on a portion of the proximal surface, with the perforated areas 157 being free of adhesive to provide enhanced fluid communication through the perforated areas 157. As will be appreciated, other configurations of adhesive on the proximal surface 156 may be provided other than the perforated configuration illustrated in FIG. 17, provided that the adhesive coating on the proximal surface 156 is sufficient to provide a desired level of adhesion of the proximal surface 156 to the patient's skin while not unduly inhibiting fluid communication to the absorbent material of the absorbent pad 150.

[0048] The absorbent pad 150 can be sized to provide more or less absorbent material to change the absorbent capacity of the absorbent pad 150, for example, by changing the thickness of the absorbent pad or the percentage of the area of ​​the proximal surface 152 of the mounting pad 102 that is provided by the proximal surface 156 of the absorbent pad 150. As will be appreciated, the more area of ​​the proximal surface 152 that is comprised by the proximal surface 156, the less of the exposed proximal surface of the structural sheet 154. In one alternative embodiment, the proximal surface 156 of the absorbent pad 150 can comprise the entire proximal surface 152 of the mounting pad 102, and in such alternative embodiment, the proximal surface 156 can have an adhesive exposed on a portion of the proximal surface to adhere the mounting pad 102 to the patient while other portions of the proximal surface are free of adhesive, for example having a perforated adhesive pattern as illustrated in FIG. 17 or other adhesive pattern on the proximal surface 156. In embodiments in which the proximal surface 156 of the absorbent pad 150 comprises the entirety of the proximal surface 152 of the mounting pad 102, the mounting pad 102 may still include a structural sheet 154 adhered to the distal surface of the absorbent pad 150 to increase the durability of the mounting pad 102, provide structural support to the absorbent pad 150, and / or provide a protective covering over the distal surface of the absorbent pad 150. The structural sheet 154 may be made of any material used in the manufacture of wound dressings, such as a polymeric material.

[0049] Reference is now made to Figures 18-20 in conjunction with Figures 1-17 in connection with an exemplary embodiment of a fixation device including a compression retainer. Figures 18-20 show an exemplary embodiment of a fixation device 100' that has the same features and operational capabilities as the fixation device 100 shown in Figures 1-17, but also includes a compression retainer 160. Figure 18 shows the tube passage 116 in an expanded cross-sectional passage configuration to receive the insertion of the medical tube 120 for positioning within the fixation sleeve 106, and the compression retainer 160 positioned to hold the fixation sleeve 106 in a compressed configuration.

[0050] FIGURE 18 illustrates the fixation device 100' attached to the patient's skin 124 via the mounting pad 102, with the medical tube 120 positioned through the fixation device 100' and into the patient's body. In FIGURE 19, the compression retainer 160 is shown positioned to hold the fixation sleeve 106 in a compressed configuration, and the fixation device 100' is shown ready to receive the medical tube 120 for fixation. In the compressed configuration as illustrated in FIGURE 18, the fixation portion 122 of the fixation sleeve 106 and the medical tube 120 can be configured, for example, as illustrated in FIGURES 5 and 6.

[0051] FIG. 20 illustrates the fixation device 100′ after the compression retainer 160 has been manipulated such that removal of the compression retainer 160 in the exemplary embodiment of FIGS. 18-20 releases the fixation sleeve 106, and thus the fixation portion 122 of the fixation sleeve 106, from the compressed configuration, thereby lengthening the fixation sleeve 106 and correspondingly contracting the cross-sectional area of ​​the tube passageway 116 at the fixation portion 122 to grip the medical tube 120 within the tube passageway 116. As shown in FIG. 20, when the compression retainer 160 is removed, the fixation portion 122 of the fixation sleeve 106 and the medical tube 120 may be in a configuration as shown in FIGS. 7 and 8, for example. As will be appreciated, other configurations of the compression retainer are possible, for example, the fixation sleeve 106 may be released from the compressed configuration without removing the compression retainer from the other components of the fixation sleeve 100′. For example, the compression retainer may be pivotally or slidably coupled to other components of the fixation device 100' such that it is operable to release the fixation sleeve 106 from the compressed configuration without disconnecting the compression retainer from the other assembled components of the fixation device 100'. However, to eliminate complications and obstacles that may arise if the compression retainer 160 is not fully removed from the other remaining components of the fixation device 100', it is preferred to fully disengage and remove the compression retainer 160 as shown in FIG.

[0052] 18 and 19, when the compression retainer 160 is positioned to retain the fixation sleeve 106 and fixation portion 122 in the compressed configuration, the compression retainer 160 has retention protrusions 166 and 168 that respectively engage with an upper surface 162 of the distal collar 110 and a locking recess 164 on the extension portion 114 of the base member 108. The compression retainer 160 includes a handle tab 170 that is configured to be easily grasped by a medical practitioner to remove the compression retainer 160, thereby releasing the fixation sleeve 106 from the compressed configuration.

[0053] 20 , with compression retainer 160 disengaged from upper surface 162 of distal collar 110 and locking recess 164 in extension portion 114 of base member 108, distal collar 110 may be pushed toward extension portion 114 to compress fixation sleeve 106 into the compressed configuration. Then, while holding fixation sleeve 106 in the compressed configuration, compression retainer 160 may be positioned to engage upper surface 162 and locking recess 164 to hold fixation sleeve 106 in the compressed configuration, for example, to allow convenient repositioning or replacement of medical tube 120 or to allow removal and replacement of fixation device 100 without removing medical tube 120. It will also be appreciated that the fixation device 100' may be initially provided in its product form with a pre-attached compression retainer 160 for retaining the fixation sleeve 106 in a compressed configuration until the fixation device 100' is to be used to secure the medical tube 120. Alternatively, the fixation device 100' may be initially provided in its product form without a pre-attached compression retainer 160 for retaining the fixation sleeve 106 in a compressed configuration, and the compression retainer 160 may be attached as needed to retain the fixation sleeve 106 in a compressed configuration while the medical tube 120 is inserted into the fixation sleeve 106 for positioning, prior to gripping the medical tube 120 with the fixation portion 122 of the fixation sleeve 106. Providing the fixation device 100' in its product form with a pre-attached compression retainer 160 provides the advantage of not needing to attach the compression retainer 160 prior to inserting the medical tube 120 into the fixation portion 122 of the fixation sleeve 106. However, providing the fixation device 100' in a product form that does not have a pre-attached compression retainer 160 for retaining the fixation sleeve 106 in a compressed configuration can provide the advantage of extending the shelf life of the fixation device 100' without the fixation sleeve 106 losing its ability to expand as a result of being stored for an extended period of time in a state where it is retained in a compressed configuration.

[0054] After use of a retention device such as retention device 100 has been completed, the retention device can be peeled off from the patient. Peeling can include applying alcohol or other solvent with a cotton swab, wipe, or the like around the edge of the mounting pad to break down the adhesive, thereby allowing the adhesive pad to be more easily peeled off from the patient's skin. As a portion of the adhesive pad is peeled off from the skin, the solvent can continue to be applied around the adhesive portion of the adhesive pad until all of the adhesive portion of the adhesive pad is peeled off from the skin. Prior to peeling off the retention device, the retention sleeve can be manipulated to release the medical tubing and remove the medical tubing from the patient and retention sleeve. Alternatively, the retention device and the secured medical tubing can be removed as a unit, or the medical tubing can be gripped by the secured portion of the retention sleeve while the retention device is being removed from the patient, allowing the proximal end of the medical tubing to be pulled from the patient as the retention device is removed. When the medical tubing remains secured to the retention device while the retention device is being removed from the patient, the medical tubing may or may not be held in a bent configuration by the bent sleeve holder of the retention device. Holding the medical tubing in a bent shape helps prevent the medical tubing from moving relative to the fixturing device when the fixturing device is removed, or alternatively, the medical tubing may be released from the bent configuration before the fixturing device is removed.

[0055] Reference is now made to FIGS. 21-32, in conjunction with FIGS. 1-17, in connection with further describing features of the exemplary fixturing device 100 and an exemplary method of manufacturing the exemplary fixturing device 100.

[0056] FIG. 21 illustrates the components and relative positions for a coupling structure between a fixation sleeve 106 for the fixation device 100 of FIG. 1 and a structural sheet 154 for the mounting pad 102. As shown in FIG. 21, the fixation sleeve 106 is disposed through an opening through a base member 108. A proximal end 180 of the fixation sleeve 106 is disposed between a proximal surface of the base member 108 and a distal surface of the structural sheet 154. Disposed on the distal surface of the structural sheet 154 is an adhesive layer 182 of a pressure sensitive adhesive. As will be appreciated, adhesive may also or alternatively be provided on the distal surface of the structural sheet 154.

[0057] 22-26 illustrate a process for joining the base member 108, the retention sleeve 106, and the structural sheet 154. FIG. 22 illustrates the retention sleeve 106 with a flaring tool 184. The flaring tool 184 is placed through an opening in the base member 108 and inserted into the proximal end of the retention sleeve 106 to flare the proximal end 180 of the retention sleeve 106. FIG. 23 illustrates the compression ring tool 186 placed on the mandrel portion on top of the flaring tool 184. The compression ring tool 186 is advanced over the mandrel portion to press the distal surface of the structural sheet 154 against the proximal surface of the base member 108 with the proximal end 180 of the retention sleeve 106 positioned between the proximal surface of the base member 108 and the distal surface of the structural sheet 154. As the compression ring tool 186 advances along the mandrel portion of the flaring tool 184, advancing the structural sheet 154 toward the base member 108, the distal surface of the structural sheet 154 engages the proximal end 180 of the fixation sleeve 106. As a result, the proximal end 180 continues to be flattened between the proximal surface of the base member 108 and the distal surface of the structural sheet 154, and flared to a 90° flare angle with the proximal end 180 in contact with the pressure sensitive adhesive of the adhesive layer 182 (not shown in FIG. 23, but shown in FIG. 21). FIG. 24 shows the compression ring tool 186 fully advanced. In the configuration shown in FIG. 24, the compression ring tool 186 is pressed toward the base member 108 with sufficient force to bond the proximal surface of the base member 108 to the distal surface of the structural sheet 154 with the pressure sensitive adhesive. As a result, the flared proximal end 180 of the fixation sleeve 106 is sandwiched between the proximal surface of the base member 108 and the distal surface of the structural sheet 154 and held by the adhesive. Figures 25 and 26 show the resulting first pre-product form 188 after removal of the compression ring tool 186 and the flaring tool 184. The first pre-product form 188 includes the base member 108, the fixation sleeve 106, and the structural sheet 154.

[0058] 27-29 show a process for attaching the rotating member 112 with the bent sleeve holder 130 to the first pre-product form 188 shown in FIGS. 25 and 26. As shown in FIGS. 27 and 28, with the proximal surface of the rotating member 112 facing the distal surface of the base member 108 and the locking sleeve 106 already placed through the opening in the rotating member 112, the rotating member 112 is advanced along the locking sleeve 106 toward the extension portion 114 of the base member 108. FIG. 27 shows that the extension portion 114 of the base member 108 includes a first lip ring 190 and a second lip ring 192, with the locking recess 164 being between the first lip ring 190 and the second lip ring 192. The extension portion 114 also includes a circular groove track 194 between the second lip ring 192 and a flange surface 196 of the base member 108. The rotating member 112 is advanced over the fixed sleeve 106 and past the extension portion 114 of the base member 108 until the rotating member 112 engages the circular groove track 194. The rotating member 112 is made of a suitably flexible material to allow the perimeter material of the opening to flex past the first lip ring 190 and past the second lip ring 192 to snap into place within the circular groove track 194 while being rotatable relative to the extension portion 114 of the base member 108. As shown in FIG. 28, the rotating member 112 is advanced to engage the extension portion 114, aligning the projections 144 with corresponding recesses 142 to position the engaged rotating member 112 at a desired radial position relative to the base member 108. FIG. 29 shows an assembled second pre-product form 200 with the rotating member 112 added.

[0059] 30-33 illustrate the process of adding a distal collar 110 to the distal end of the fixation sleeve 106 of the second preproduct form 200. The collar assembly of the distal collar 110 includes a collar member 202 having a collar nipple 204 and a retaining member 206. FIG. 30 illustrates the fixation sleeve 106 placed through an opening through the retaining member 206 and the collar member 202 positioned to engage the distal end 210 of the fixation sleeve 106 with an insertion tool 212. FIG. 31 illustrates the tip of the insertion tool 212 inserted into the distal end 210 of the fixation sleeve 106. FIG. 32 illustrates the insertion tool 212 fully advanced into the distal end 210 of the fixation sleeve 106 with the distal end of the fixation sleeve 106 contacting the stop collar 214 of the insertion tool 212. The retaining member 206 is then advanced over the distal end 210 of the fixation sleeve 106 and biases the sleeve wall of the distal end 210 against the collar nipple 204. The retaining member 206 is advanced until the distal end of the retaining member 206 abuts, and preferably contacts, the distal collar portion 216 of the collar member 202. The assembled collar member 202 and the retaining member 206 retaining the distal end 210 form the distal collar 110. This distal collar 110 is illustrated in a resulting third pre-product form 220 in FIG.

[0060] Refer now to FIG. 34, which illustrates the process of preparing the fixation device 100 of FIG. 1 by adding an absorbent pad 150 to the third pre-product form 220 to complete the mounting pad 102. FIG. 34 also illustrates the preparation of a medical drain fixation product comprising a fixation device and a releasable backing by adding a releasable backing on the proximal surface 152 of the mounting pad 102. FIG. 34 illustrates a pressure sensitive adhesive layer 222 applied to the proximal surface of the structural sheet 154 in the third pre-product form. The absorbent pad 150 is attached to the proximal surface of the structural sheet 154 using a portion of the adhesive layer 222 with the apertures 158 of the absorbent pad 150 aligned with the apertures 224 of the adhesive layer 222 and the corresponding apertures of the structural sheet 154. As shown in FIG. 34, the structural sheet 154, the adhesive layer 222, and the absorbent pad 150 comprise the mounting pad 102 when assembled. The adhesive layer 222 may include an antimicrobial agent, similar to the discussion of the antimicrobial potential of the absorbent pad 150. Aligned openings through the absorbent pad 150, adhesive layer 222, and structural sheet 154 form portions of the tube passage 116 through the mounting pad 102. As shown in FIG. 34, addition of the mounting pad 102 to the third pre-product form 220 forms the fastening device 100 of FIG.

[0061] Also shown in Figure 34 is the application of a releasable backing material onto the proximal surface 152 (shown in Figure 16) of the mounting pad 102. The releasable backing material is adhered to the mounting pad 102 via an adhesive layer 222 to form the medical tube fixation product 240. In the illustrated example of Figure 34, the releasable backing material includes two flexible backing sheets (backing pieces) 228a, 228b that are adhered to the adhesive layer 222 around the absorbent pad 150 and cover the absorbent pad 150. The flexible backing sheets 228a, 228b have peel tabs 230a, 230b that can be grasped and pulled apart by a person to peel the releasable backing sheets (228a, 228b) from the mounting pad 102 to expose the absorbent pad 150 and the adhesive (adhesive) layer 222 around the absorbent pad 150. For example, during use of the fixation device 100, the proximal surface 152 of the mounting pad 102 can be adhered to the patient's skin.

[0062] As will be appreciated, a fixation device 100' with an engaged compression retainer 160 as shown in FIGS. 18 and 19 may be made from the fixation device 100 shown in FIG. 34 by compressing the fixation sleeve 106 into a compressed configuration as shown in FIGS. 18 and 19 and positioning the compression retainer 160 to engage the distal collar 110 and extension portion 114 of the base member 108 to hold the fixation sleeve 106 in the compressed configuration. In this manner, a medical tube fixation product 240 may be prepared to include the fixation device 100' by including the compression retainer 160. The compression retainer 160 may be included pre-attached to hold the fixation sleeve 106 in the compressed configuration, or the compression retainer 160 may be included but not pre-attached in such a manner. For example, the compression retainer 160 may be included as a separate piece that can be attached as desired by a medical practitioner to hold the fixation sleeve 106 in the compressed configuration.

[0063] Reference is now made to FIG. 35, which illustrates an example of a kit 300 including a medical tube securement product 302. The medical tube securement product 302 includes a medical tube securement device 304 disposed within a hermetically sealed enclosure 306. The medical tube securement device 304 can be, or include features of, the exemplary securement device 100 or exemplary securement device 100′ illustrated or described in connection with any of FIGS. 1-34, the exemplary securement device 350 illustrated or described in connection with any of FIGS. 36-38, or the exemplary securement device 100′ or exemplary securement device 100″ illustrated or described in connection with any of FIGS. 39-51, for example. The medical tube securement device 304 can be in the form of, or have any features of, the medical tube securement product 302 including a releasable backing, with or without a compression retainer, as illustrated for the medical tube securement product 240 illustrated in FIG. 34. The medical tubing securement device 304 is preferably sterilized within the sealed housing 306. Sterilization of the medical tubing securement device 304 can occur before or after sealing the medical tubing securement device 304 within the sealed housing 306. In one preferred method, the medical tubing securement device 304 is sterilized after sealing within the sealed housing 306 by exposure to radiation that penetrates the sealed housing 306 and sterilizes the medical tubing securement device 304 within the sealed housing 306. The sealed (hermetically sealed) housing 306 may be made, for example, of a polymeric material of the type used for packaging medical devices. Although the kit 300 is illustrated as including only a single medical tubing securement product 302, in alternative variations, such a kit 300 may include any number of such medical tubing securement products 302.

[0064] With continued reference to FIG. 35, kit 300 includes at least one additional component 308a, but may include multiple additional components. While kit 300 is illustrated in FIG. 35 as including optional additional components 308b and 308c, it will be understood that the kit may include any number of additional components greater than three. An example of a product type for additional component 308a includes medical tubing 120, or any other of the product types disclosed herein for additional products of the kit. When multiple additional components are included in kit 300, each of the additional components may be the same type of product, or different ones of the additional components may be different types of products.

[0065] Reference is now made to FIGS. 36-38 in connection with another embodiment of a medical tube retention device having the ability to selectively retain a medical tube in a bent configuration. FIGS. 36-38 illustrate an exemplary medical tube 364 retention device 350 including a retention sleeve 352 having a retention portion of a braided textile structure. The retention portion can be or have the properties as described above with reference to any of FIGS. 1-20, for example. Retention device 350 includes a base structure including a mounting pad 354, a base member 356, a retention member 358, and a movable bail member 360. Retention device 350 also includes a distal collar 362. Retention sleeve 352 has a proximal end retained in the base structure and a distal end retained in distal collar 362. The fixation sleeve 352, fixation portions of the fixation sleeve 352, the mounting pad 354, the base member 356, and the distal collar 362 may have the same or similar features as previously described for the corresponding features illustrated in any of Figures 1-34. For purposes of illustration, the fixation device 350 is shown with a medical tube 364 disposed through a tube passageway through the fixation device 350 and secured to the fixation device 350 by the fixation portions of the fixation sleeve 352.

[0066] The securing device 350 includes a bent sleeve holder provided by cooperating features of the base member 356 and the bail member 360. The bail member 360 is movable between a first configuration in which the securing sleeve 352 is not held in a bent configuration, as shown in FIG. 36, and a second configuration in which the securing sleeve 352 is held in a bent configuration, as shown in FIGS. 37 and 38. When the bail member 360 is moved from the first configuration, as shown in FIG. 36, to the second configuration, as shown in FIGS. 37 and 38, the bail member 360 contacts the securing sleeve 352, thereby biasing the securing sleeve 352 into the bent configuration. The retaining member 358 includes a locking feature that locks the bail member 360 in place when the bail member 360 is positioned in the second configuration. The locking feature is in the form of a depressible tab 370 having a lip projection. The bail member 360 is returned to the first configuration by depressing the tab 370 sufficiently to move the bail member 360 over the lip projection, and may be released from the second configuration by correspondingly releasing the locking sleeve 352 from the bowed configuration.

[0067] In the illustrated embodiment of the fixation sleeve 352 in Figures 36-38, the retaining member 358 is fixed in position relative to the base member 356 and the mounting pad 354. However, in an alternative embodiment, the retaining member 358 may be rotatably mounted to the base structure such that the retaining member 358 is rotatable to different radial positions relative to the base member 356 and the mounting pad 354 to allow the fixation sleeve 352, in a bent configuration, to be bent in different radial directions relative to the longitudinal axis of the tube passage through the mounting pad 354 and the base member 356, similar to the operation of the rotating member 112 illustrated in the fixation device 100 in Figures 1-16, 18-20, and 34.

[0068] Reference is now made to FIGS. 39-42, which illustrate another embodiment of a medical tube retention device 100″ having similar features as the retention device 100 of FIGS. 1-16. The reference numerals identifying the features of the retention device 100″ are the same as the reference numerals used in FIGS. 1-16 to identify similar features. Similar but modified alternative features are identified by similar reference numerals with an apostrophe (′ symbol) added to the end. In contrast to the retention device 100 of FIGS. 1-16, the retention device 100″ shown in FIGS. 39-42 includes an alternative configuration of a distal collar 110′, a rotating member 112′ and a bent sleeve holder 130′.

[0069] 39-42, the bent sleeve holder 130' includes a retaining channel 132' that is open toward the distal surface 104 of the mounting pad 102 to receive a portion of the fixation sleeve 106 so as to hold the fixation sleeve 106 in a bent configuration with the distal portion of the fixation sleeve 106 biased toward the patient's skin when the mounting pad 102 is secured to the skin. The retaining channel 132' is mechanically reinforced with reinforcing ribs 402, which help stabilize the retaining channel 132' and reduce the risk of the retaining channel 132' twisting or bending during use. On the side of the retaining channel 132' opposite the reinforcing ribs 402, the wall of the retaining channel 132' includes an open side 404 to facilitate insertion and removal of the bent fixation sleeve 106 into and from the retaining channel 132'.

[0070] Similar to the fixation device 100 shown in FIGS. 1-16, the fixation device 100'' includes a curved sleeve holder 130' supported by a rotating member 112'. The rotating member 112' is similar to the rotating member 112 of the fixation device 100 shown in FIGS. 1-16, except that the design of the manipulation tabs 146' is somewhat modified, so that the rotating member 112' has five protrusions 144' (shown in FIG. 40) instead of three corresponding protrusions as shown in FIGS. 1-16. Similar to the fixation device 100 shown in FIGS. 1-16, the rotating member 112' is rotatable to different radial positions relative to the base member 108. The base member 108 of the fixation device 100'' has the same configuration as shown for the fixation device 100 of FIGS. 1-16. Recesses (not shown in FIGS. 39-42) in the base member 108 are configured to receive the projections 144' for locking the rotating member 112' at different radial positions. The manipulation tabs 146' are deformable in the same manner as described for the manipulation tabs 146 in FIGS. 1-16, thereby allowing a user to elastically deform a portion of the rotating member 112' to engage and disengage the projections 144' with corresponding recesses in the base member 108. FIGS. 41 and 42 show the fixation device 100' with the fixation sleeve 106 received within the retaining channel 132' of the bent sleeve holder 130', thereby locking the rotating member 112' with respect to the base member 108 at different radial positions.

[0071] The alternative design of the bent sleeve holder 130' enhances retention of the fixation sleeve 106 in a bent (folded) configuration, and it has been found that there is less risk of the fixation sleeve 106 being inadvertently bent out of the sleeve holder 130' during use.

[0072] An alternative distal collar 110' of the fixation device 100'' of Figures 39-42 is configured with a waterfall-like design to retain the distal end of the fixation sleeve 106, the features of which may be better understood with reference to Figures 43-49.

[0073] The manufacture of the fixation device 100'' is similar to the method illustrated in and described with reference to FIGS. 21-34, except for the modified process for assembling the modified distal collar 110'' of the fixation device 100''. Reference is now made to FIGS. 43-49, which show the assembly of the distal collar 110'' during the manufacture of the fixation device 100''. FIG. 43 shows a second pre-product form 200' comprising an intermediate assembly of the structural sheet 154, the base member 108, the rotating member 112', the fixation sleeve 106, and the bent sleeve holder 130'. The rotating member 112' is held by and rotatable relative to the extension portion 114 of the base member 108. The second pre-product form 200' is similar to the second pre-product form 200 illustrated in FIG. 29 during the manufacture of the fixation device 100 of FIGS. 1-16.

[0074] FIG. 43 illustrates a waterfall collar 410 positioned on the fixation sleeve 106 of the second preproduct form 200′ during assembly of the distal collar 110′ of the fixation device 100″ of FIGS. 39-42. As shown in FIG. 43, a tip of a flaring tool 412 is inserted into the distal end 210 of the fixation sleeve 106. The flaring tool 412 is advanced into the fixation sleeve 106 to flare the distal end 210 of the fixation sleeve 106, as shown in the sequential steps illustrated in FIGS. 44 and 45. After full advancement of the flaring tool 412 flares open the distal end 210 of the fixation sleeve 106 as shown in FIG. 45, the waterfall collar 410 is positioned adjacent the flared distal end 210 of the fixation sleeve 106 such that the waterfall sleeve 414 advances over the flaring tool 412 and engages the flared distal end 210 of the fixation sleeve 106 as shown in FIG. 45. As the waterfall sleeve 414 is further advanced over the waterfall collar 410, the waterfall sleeve 414 is advanced over the waterfall collar 410 such that the flared distal end 210 of the fixation sleeve 106 folds over the waterfall collar 410 in a waterfall configuration around the outside of the waterfall collar 410 as shown in FIG. The waterfall sleeve 414 is advanced over the folded-over portion of the distal end 210 of the waterfall collar 410 until the advanced end of the waterfall sleeve 414 is adjacent the bottom lip portion of the waterfall collar 410. The flaring tool 412 is then removed from the fixation sleeve 106, as shown in FIG. 47. As shown in FIG. 48, the waterfall retainer 416 is then placed over the waterfall sleeve 414 to engage and couple to the waterfall collar 410 to form the final assembled distal collar 110' for the fixation device 100''. The completed configuration of the distal collar 110' is illustrated in partial cross-section in FIG. 49.The flared distal end 210 of the fixation sleeve 106 is shown folded over and positioned between the waterfall collar 410 and the waterfall sleeve 414, with the waterfall retainer 416 engaging the waterfall collar 410. Completion of the manufacture of the fixation device 100'' may then proceed with the addition of an absorbent pad 150 similar to that shown in FIG. 34, and the fixation product may be formed by adding a removable backing, such as provided by removable backing sheets (228a, 228b) similar to that shown in FIG.

[0075] The fixation device 100" can also be combined with a compression retainer similar to the configuration of the fixation device 100" illustrated in Figures 18-20. Referring to Figure 50, Figures 39-49 together illustrate the fixation device 100" in a compressed configuration with the compression retainer 160' engaging the distal collar 110' and the extension 114 of the rotating member 112' to hold the fixation sleeve 106 in an expanded cross-sectional area (passage cross-sectional area) of the tube passage 116 through the fixation sleeve 106 to receive the insertion of the medical tube 120 for positioning within the fixation sleeve 106. The compression retainer 160' is of a similar design to the compression retainer 160 of Figures 18-20, but includes an upper keyhole cutout for snapping around a correspondingly shaped upper protrusion on the distal collar 110' to more securely hold the fixation sleeve 106 in the compressed configuration for application of the fixation device 100" to a patient during a medical procedure. In Fig. 50, fixation device 100''' is shown with medical tube 120 already placed through fixation sleeve 106 in a compressed configuration. Fig. 51 shows fixation device 100''' after disengagement of compression retainer 160' which allows the fixation sleeve to be expanded to secure medical tube 120 to fixation sleeve 106, thereby gripping medical tube 120.

[0076] <Example implementation combination> Some other contemplated embodiments of combinations of implementations relating to various aspects of the present disclosure, with or without additional features as disclosed above or elsewhere in this specification, are summarized in the numbered paragraphs presented below and in the appended claims.

[0077] <Paragraph 1> In some embodiments, a fixation device is provided for securing a medical tube to a patient when inserted into the patient, the fixation device comprising: a mounting pad configured to interface with the patient's skin to attach the fixation device to the skin, the mounting pad preferably having an adhesive surface for adhering the mounting pad to a surface of the skin; a variable length fixation sleeve having a proximal end and a distal end at an opposite longitudinal end to the proximal end, the variable length fixation sleeve being coupled to the mounting pad via a coupling structure adjacent the proximal end of the fixation sleeve; a tube passage configured to receive the medical tube for fixation to the patient, the tube passage extending longitudinally through the fixation sleeve; Equipped with the fixation sleeve includes a fixation portion through which the tube passage extends, a cross-sectional passage area of ​​the tube passage in the fixation portion transverse to a longitudinal path of the tube passage increases as the fixation sleeve shortens and decreases as the fixation sleeve lengthens, the length of the fixation sleeve being adjustable to increase the cross-sectional passage area to receive the medical tube for translation through the tube passage in the fixation portion and decrease the cross-sectional passage area to grip the medical tube in the tube passage by the fixation portion to secure the medical tube to the fixation device. Fixed device.

[0078] <Bent sleeve retainer> (Bent sleeve retainer) <Paragraph 2> the fixation device further comprises a bent sleeve holder selectively engageable and disengageable with the fixation sleeve to selectively retain and not retain the fixation sleeve in a bent configuration; In the bent configuration, the fixation sleeve has a bend around which a tube passage is correspondingly bent, and preferably, in the bent configuration, the bend biases a portion of the sleeve distal to the bend toward the mounting pad. The fixation device described in paragraph 1.

[0079] <paragraph 3> In the bent configuration, the fixation sleeve is bent (bent) through an angle of at least 60°, preferably at least 80°, more preferably at least 90°, between the distal and proximal ends of the fixation sleeve; A fastening device as described in paragraph 2.

[0080] <Paragraph 4> In the bent configuration, at least a longitudinal portion of the fixation portion of the fixation sleeve is bent. A fastening device as described in paragraph 2 or paragraph 3.

[0081] <paragraph 5> the bent sleeve holder engages at least a longitudinal portion of the fixed portion of the fixation sleeve when the fixation sleeve engages the bent sleeve holder to hold the fixation sleeve in the bent configuration; A fixation device according to any one of paragraphs 2 to 4.

[0082] <Paragraph 6> The bent sleeve holder includes a movable member, The movable member is a first configuration in which the fixing portion (fixing member) is not retained in the bent configuration; a second configuration in which the movable member contacts and is biased against the fixed sleeve in the bent configuration; and It is movable between 6. A fixation device according to any one of paragraphs 2 to 5.

[0083] <Paragraph 7> The fixation device further comprises a lock configured to retain the movable member in the second configuration when the movable member is repositioned from the first configuration to the second configuration. A fastening device as described in paragraph 6.

[0084] <Paragraph 8> the lock being selectively releasable to permit repositioning of the movable member from the second configuration to the first configuration. A fastening device as described in paragraph 7.

[0085] <Paragraph 9> the bent sleeve holder includes a retaining channel within which a corresponding portion of the fixation sleeve is receivable in a received position to retain the fixation sleeve in the bent configuration; 6. A fixation device according to any one of paragraphs 2 to 5.

[0086] <Paragraph 10> the bent sleeve holder includes a flexible tab; the flexible tab flexes when a corresponding portion of the fixation sleeve is inserted into the retaining channel to receive the fixation sleeve in the receiving position, thereby holding the fixation sleeve in a bent configuration, and flexes when a corresponding portion of the fixation sleeve is removed from the retaining channel to release the fixation sleeve from the bent configuration; A fastening device as described in paragraph 9.

[0087] <Paragraph 11> said flexible tab, and optionally the entire bent sleeve holder, being made from a polymeric structural material, preferably a thermoplastic elastomer; Optionally selected from the group consisting of thermoplastic polyurethanes, thermoplastic vulcanizates, and combinations thereof; A fastening device as described in paragraph 10.

[0088] <Paragraph 12> the flexible tab, and optionally the entire bent sleeve holder, are made from a material of construction having a hardness in the range of 60 to 90 Shore A durometer; A fixing device according to paragraph 10 or 11.

[0089] <Paragraph 13> the bent sleeve holder comprises a channel member having a flexible tab portion, the channel member being made from a structural material; A fixation device according to paragraph 11 or 12.

[0090] <Paragraph 13.1> the retention channel opens away from the mounting pad; 14. A fixation device according to any one of paragraphs 9 to 13.

[0091] <Paragraph 13.2> the retention channel is open toward the mounting pad; 14. A fixation device according to any one of paragraphs 9 to 13.

[0092] <Paragraph 14> the bent sleeve holder is rotatably mounted and rotatable at different radial positions relative to the mounting pad; Preferably, said bent sleeve holder maintains a constant standoff from said mounting pad at all said radial positions; Optionally, the different radial locations are radially spaced apart by radial intervals of 30 degrees or less, preferably 15 degrees or less, optionally at least 5 degrees; Preferably, the proximal end of the fixation sleeve is in a fixed position relative to the mounting pad; Rotation of the bent sleeve holder relative to the mounting pad also rotates the bent sleeve holder relative to the fixed sleeve. 10. A fixation device according to any one of paragraphs 2 to 13.2.

[0093] <Paragraph 15> the radial locations being radially spaced about a longitudinal axis of a tube passage through the mounting pad. A fastening device as described in paragraph 14.

[0094] <Paragraph 16> the mounting pad has a proximal side that is positioned against the patient's skin during use; the radial locations are radially spaced about an axis perpendicular to a face of the proximal surface of the mounting pad. A fastening device as described in paragraph 14 or 15.

[0095] <Paragraph 17> a radial positioning lock for selectively locking the bent sleeve holder at different ones of the plurality of radial positions. 17. A fixation device according to any one of paragraphs 14 to 16.

[0096] <Paragraph 18> The bent sleeve holder is rotatable about an axis of rotation through at least 90 degrees, preferably at least 180 degrees, more preferably at least 360 degrees. 18. A fixation device according to any one of paragraphs 14 to 17.

[0097] <Paragraph 19> The fixation device further comprises: A base member; a rotating member that is rotatable relative to the base member; It is equipped with the bent sleeve holder is supported on the rotating member, preferably the base member having a fixed orientation relative to the mounting pad, such that rotation of the rotating member relative to the base member also results in rotation of the rotating member relative to the mounting pad. 19. A fixation device according to any one of paragraphs 14 to 18.

[0098] <Paragraph 20> the base member and the rotating member include corresponding interlocking first and second locking structures selectively engageable to lock the radial position of the rotating member at different ones of the plurality of radial positions. A fastening device as described in paragraph 19.

[0099] <Paragraph 21> the rotating member having at least a portion that is elastically deformable to disengage the first locking structure and the second locking structure to permit repositioning of the bent sleeve holder between different radial positions. A fastening device as described in paragraph 20.

[0100] <Paragraph 22> the rotating member, and optionally the base member, are made of a polymeric construction material, preferably a thermoplastic elastomer, optionally selected from the group consisting of thermoplastic polyurethanes, thermoplastic vulcanizates, and combinations thereof; both the rotating member and the base member are made of the polymeric composite material; The properties (e.g., hardness) of the polymeric constituent materials of the rotating member and the base member may be the same or different; 22. A fastening device according to any one of paragraphs 19 to 21.

[0101] <Paragraph 23> the rotating member, and optionally the base member, are made from a material of construction having a hardness in the range of 60 to 90 Shore A durometer; A fastening device according to paragraph 22.

[0102] <Paragraph 24> the bent sleeve holder and the rotating member are present in a single molded part, preferably in a single injection molded part, preferably the single molded part being made from a single component material; 24. A fixation device according to any one of paragraphs 19 to 23.

[0103] <Paragraph 25> the base member includes an extension portion that extends through an aperture in the rotatable member, the rotatable member being rotatable about the extension portion; Optionally, the rotating member is retained in a circular groove track extending around a periphery of the extension portion and is rotatable relative to the circular groove track. 25. A fixation device according to any one of paragraphs 19 to 24.

[0104] <Paragraph 26> the base member is a molded part, preferably an injection molded part; Optionally, the molded part of the base member is made from a single component material. 25. A fixation device according to any one of paragraphs 19 to 24.

[0105] <Paragraph 27> the bent sleeve holder is configured to hold the fixation sleeve in the bent configuration, and an entire length of the tube passage in the fixation sleeve is disposed within a standoff distance from a proximal surface plane of the mounting pad; a minimum insertion cross-section of the tube passage in the fixed portion, across a longitudinal path of the tube passage through the fixed portion, varies in size as the length of the fixation sleeve is varied, the minimum insertion cross-section having a maximum cross-sectional dimension (e.g., diameter in a preferred implementation when the minimum insertion cross-section is circular) that varies correspondingly as the size of the minimum insertion cross-section is varied; the standoff distance is no more than 10 times, preferably no more than 7 times, more preferably no more than 6 times, a relaxed state maximum cross dimension of a minimum insertion cross section of the tube passage through the retention sleeve, and optionally is preferably at least 3 times, or even at least 4 times, the relaxed state maximum cross dimension; The relaxed state maximum cross-sectional dimension is the maximum cross-sectional dimension of the smallest insertion cross-section when the fixation sleeve is in a relaxed state with no applied compression or tension in the longitudinal direction, and as will be appreciated, the maximum cross-sectional dimension in the relaxed state typically does not correspond to the bent configuration, and as will be appreciated, the relaxed state maximum cross-sectional dimension will typically be slightly smaller than the maximum medical outer cross-sectional dimension (e.g., diameter) of a medical outer cross-section of a portion of the medical tube designed to receive the fixation sleeve for fixation at the fixation portion. In one example, such standoff distance for a sleeve designed to hold a 5 millimeter diameter medical tube may preferably be about 24 millimeters. 27. A fixation device according to any one of paragraphs 2 to 26.

[0106] <Compression retainer> (Compression retainer) <Paragraph 28> The fixation device further comprises a compression retainer arranged to hold the fixation sleeve in a compressed configuration; when the fixation portion of the fixation sleeve is under the longitudinally applied compression, the passage cross-sectional area is in an expanded configuration to receive the medical tube therethrough. 28. A fixation device according to any one of paragraphs 1 to 27.

[0107] <Paragraph 29> the compression retainer is operable to release the fixation portion from the longitudinally applied compression to lengthen the fixation sleeve, thereby constricting the passage cross-sectional area to the expanded configuration, to allow the fixation portion to grip the medical tube when positioned through the tube passage through the fixation portion. A fastening device as described in paragraph 28.

[0108] <paragraph 30> the compression retainer is removable to allow the passage cross-sectional area to be reduced by releasing the fastener from the longitudinal compression and thereby lengthening the fastener sleeve relative to the compressed configuration. 29. A fastening device as described in paragraph 29.

[0109] <Paragraph 31> The fixation device comprises: a distal collar adjacent a distal end of the fixation sleeve; a base structure adjacent a proximal end of the fixation sleeve; It is equipped with the compression retainer engages the distal collar and the base structure to retain the fixation sleeve in the compressed configuration. A fastening device according to any one of paragraphs 28 to 30.

[0110] <Paragraph 32> The fixation device comprises the rotating member and the base member according to any one of paragraphs 19 to 26, a base structure comprising the base member, the base member comprising the extension portion according to paragraph 25 extending through an opening in the rotating member, the rotating member being rotatable about the extension portion; the compression retainer engages the extension portion when the fixation sleeve is in the compressed configuration. A fastening device according to any one of paragraphs 28 to 31.

[0111] <Paragraph 33> when the fixation sleeve is in a compressed configuration, all of the tube passages through the fixation sleeve, and preferably the tube passages through the fixation device, are maintained in a straight longitudinal configuration; 33. A fixation device according to any one of paragraphs 28 to 32.

[0112] <Paragraph 34> when the compression retainer is manipulated to release the fixation sleeve from the compressed configuration, the tube passage is released from a straight longitudinal configuration such that the fixation sleeve becomes pliable (flexible) to create a corresponding bend in the tube passage to bend (flex) the medical tube when positioned through the tube passage. A fastening device as described in paragraph 33.

[0113] <Paragraph 35> the fixation sleeve has a released configuration when the fixation sleeve is released from the compressed configuration with nothing disposed in the tube passage through the fixation sleeve, the length of the fixation sleeve being greater in the released configuration than in the compressed configuration; a minimum insert cross-section of the tube passageway within the stationary portion, across a longitudinal path of the tube passageway through the stationary portion, varies as the length of the stationary sleeve is varied, the minimum insert cross-section being greater in the compressed configuration than in the released configuration; A fixation device according to any one of paragraphs 28 to 34.

[0114] <Paragraph 36> In the compressed configuration, the minimum insertion cross section is at least 10 percent greater than in the released configuration. A fastening device as described in paragraph 35.

[0115] <Paragraph 37> the minimum insert cross section has a maximum cross dimension, preferably the minimum insert cross section is circular and the maximum cross dimension is a diameter of the circular minimum insert cross section; in the released configuration, the maximum cross-sectional dimension of the minimum insertion cross-section in the released configuration is at least 0.5 millimeters smaller than in the compressed configuration, preferably at least 1.0 millimeters smaller, more preferably at least 1.5 millimeters smaller, optionally no more than 4 millimeters smaller than in the compressed configuration, alternatively optionally no more than 3 millimeters smaller; Optionally, the maximum cross-sectional dimension of the minimum insertion cross-section is in a range of 2.5 to 26 millimeters when the fixation sleeve is in the compressed configuration. A fixation device according to paragraph 35 or paragraph 36.

[0116] <Paragraph 38> the minimum insertion cross-section has a maximum cross-sectional dimension, preferably the minimum insertion cross-section is circular and the maximum cross-sectional dimension is a diameter of the circular minimum insertion cross-section; the minimum insertion cross section is configured to receive a corresponding outer cross section of the medical tube in the compressed configuration while retaining the medical outer cross section in the released configuration, the medical outer cross section having a maximum outer cross dimension (e.g., an outer diameter of the preferred medical tube having a circular outer cross section) as a maximum outer cross dimension; In the released configuration, the maximum cross-sectional dimension of the minimum insertion cross-section is at least 0.5 millimeters smaller than the maximum medical outer cross-sectional dimension of the medical outer cross-section of the medical tube, preferably at least 1.0 millimeters smaller, more preferably at least 1.5 millimeters smaller, optionally no more than 4 millimeters smaller, or alternatively optionally no more than 3 millimeters smaller, than the maximum medical outer cross-sectional dimension of the medical outer cross-section of the medical tube. 38. A fixation device according to any one of paragraphs 35 to 37.

[0117] <Proximal Sleeve Coupling> (Proximal Sleeve Coupling) <Paragraph 39> a coupling of the fixation sleeve to the mounting pad comprising a flared proximal end material of the fixation sleeve sandwiched between a first fixation member and a second fixation member; Optionally, the flared proximal end material of the fixation sleeve flares at an angle of at least 75 degrees, preferably at least 90 degrees, relative to an adjacent non-flared portion of the fixation sleeve; Preferably, the flared proximal end material of the fixation sleeve is sandwiched between opposing surfaces, preferably opposing parallel surfaces, of the first and second fixation members. 39. A fixation device according to any one of paragraphs 1 to 38.

[0118] <paragraph 40> the flared proximal end material of the fixation sleeve is adhered to at least one, and preferably both, of the first fixation member and the second fixation member, optionally by an adhesive disposed between the first fixation member and the second fixation member; 39. A fastening device as described in paragraph 39.

[0119] <Paragraph 41> the fixation device comprises an adhesive disposed between the first fixation member and the second fixation member, the adhesive being a pressure sensitive adhesive, optionally the pressure sensitive adhesive being selected from the group consisting of an acrylic adhesive, a silicone adhesive, and combinations thereof; A fastening device as described in paragraph 40.

[0120] <Paragraph 42> The adhesive is an adhesive layer applied to at least one surface selected from the group consisting of a first surface of the first fastening member and a second surface of the second fastening member, preferably the adhesive layer comprising a pressure sensitive adhesive; Optionally, the adhesive comprises: a first adhesive layer on the first surface of the first fixation member and disposed toward the flared proximal end material of the fixation sleeve; a second adhesive layer on the second opposing surface of the second fixing member; and It is equipped with the first adhesive layer and the second adhesive layer are optionally of the same adhesive composition or optionally of different adhesive compositions, preferably the first adhesive layer and the second adhesive layer each comprise a pressure sensitive adhesive; A fixing device according to paragraph 40 or 41.

[0121] <Paragraph 43> The first fixing member is the mounting pad. 43. A fixation device according to any one of paragraphs 39 to 42.

[0122] <Paragraph 44> The second fixing member is the base member described in any one of paragraphs 19 to 26. 44. A fixation device according to any one of paragraphs 39 to 43.

[0123] Distal Collar Assembly <Paragraph 45> The distal end of the fixation sleeve is retained by a distal collar assembly. 45. A fixation device according to any one of paragraphs 1 to 44.

[0124] <Paragraph 46> The distal collar assembly includes: a collar member having a collar nipple disposed within a distal end of the fixation sleeve; a retaining member disposed over the distal end of the fixation sleeve and biasing the distal end sleeve wall toward the collar nipple; Equipped with A fastening device as described in paragraph 45.

[0125] <Paragraph 46.1> the distal collar assembly includes a waterfall fixation configuration; A fastening device as described in paragraph 45.

[0126] <Paragraph 46.2> the distal collar assembly comprises a waterfall collar; a portion of the fixation sleeve is disposed through the waterfall collar, and a flared distal end of the fixation sleeve is folded outwardly of the waterfall collar; Fixation devices as described in paragraph 46.1.

[0127] <Paragraph 46.3> the distal collar assembly includes a waterfall sleeve disposed over at least a portion of the waterfall collar; the flared distal end of the fixation sleeve is folded over the exterior of the waterfall collar; or the waterfall collar is disposed between the waterfall collar and the waterfall sleeve; Fixation devices as described in paragraph 46.2.

[0128] <Paragraph 46.4> The distal collar assembly includes a waterfall retainer disposed over the waterfall sleeve and engaged with the waterfall collar. Fixation devices as described in paragraph 46.3.

[0129] <Paragraph 47> The fixation device further comprises the compression retainer of any one of paragraphs 28-38, the compression retainer engaging the distal collar assembly to retain the fixation sleeve in a compressed configuration. A fixation device according to any one of paragraphs 45 to 46.4.

[0130] <Mounting pad and absorber> <paragraph 48> the mounting pad includes an absorbent portion configured to absorb exudate during use of the fixation device; Optionally, the mounting pad comprises a structural sheet, a distal surface of the absorbent portion that is positioned away from the patient during use of the fixation device being covered by the structural sheet, and further optionally, the mounting pad comprises an adhesive on at least a portion of a proximal surface of the structural sheet for adhesion of the mounting pad to the skin of the patient. 48. A fixation device according to any one of paragraphs 1 to 47.

[0131] <Paragraph 49> The tube passage extends through an opening in the absorbent. A fastening device as described in paragraph 48.

[0132] <Paragraph 50> the absorbent has a proximal surface disposed towards the patient when the fixation device is attached to the patient, and optionally the proximal surface of the absorbent comprises a fluid communication surface in fluid communication with the patient when the fixation device is attached to the skin of the patient, and optionally a fluid communication surface in contact with the patient. A fixation device as described in paragraph 48 or paragraph 49.

[0133] <Paragraph 51> the mounting pad comprises an adhesive surface for adhering the mounting pad to the skin of the patient, and optionally the adhesive surface is configured to adhere the adhesive pad to the skin completely around a periphery of the proximal surface of the absorbent portion configured to be positioned towards the patient. A fixation device according to any one of paragraphs 48 to 50.

[0134] <Paragraph 52> the mounting pad comprises a perforated layer of adhesive covering at least a portion of the proximal surface of the absorbent portion; and perforations through the perforated layer of adhesive providing a fluid communication passageway across the perforated layer of adhesive to provide fluid communication for exudates from the patient across the perforated layer of adhesive to be absorbed by the absorbent when the mounting pad is attached to the skin of the patient. A fastening device as described in paragraph 51.

[0135] <Paragraph 53> The absorbent portion has an absorbent capacity of at least 500% by weight, determined as the absorption to saturation of 0.9% weight / volume saline (isotonic saline) relative to the weight of the absorbent portion. A fixation device according to any one of paragraphs 48 to 52.

[0136] <Paragraph 54> The absorbent portion comprises an absorbent material optionally selected from the group consisting of hydrophilic polymers, natural fibers (e.g., cotton), hygroscopic gels (e.g., hydrogels), and combinations thereof. A fixation device according to any one of paragraphs 48 to 52.

[0137] <Paragraph 55> The absorbent portion has an absorbent capacity of at least 1 milliliter, determined as absorption to saturation of 0.9% weight / volume saline (isotonic saline), A fixation device according to any one of paragraphs 48 to 54.

[0138] <Paragraph 56> the absorbent portion having a proximal surface configured to be positioned toward the skin of the patient; Preferably, at least a portion of the proximal surface is configured to contact the skin when the fixation device is attached to the skin. A fixation device according to any one of paragraphs 48 to 55.

[0139] <Paragraph 57> The proximal surface of the absorbent has a surface area of ​​at least 4 square centimeters, optionally up to 18 square centimeters. 57. A fastening device as described in paragraph 56.

[0140] <Paragraph 58> Optionally, said mounting pad is free of adhesive covering any portion of a proximal surface of said absorbent portion; Alternatively and optionally, the mounting pad comprises an adhesive covering a portion of the proximal surface of the absorbent portion but not another portion, preferably in this alternative the adhesive on a portion of the proximal surface is present in a perforated layer of the adhesive on the proximal surface, perforations through the perforated layer of adhesive comprising some or all of the other portions of the proximal surface not covered by the adhesive, the perforations through the perforated layer of adhesive providing fluid communication across the perforated layer of adhesive to the proximal surface of the absorbent portion, allowing a flow of exudate from the patient across the perforated layer of adhesive to be absorbed by the absorbent portion when the mounting pad is attached to the skin of the patient. A fixation device as described in paragraph 56 or 57.

[0141] <Paragraph 59> The proximal surface has a circular periphery. 59. A fixation device according to any one of paragraphs 56 to 58.

[0142] <Paragraph 60> The fixation device further comprises an opening on the proximal surface of the absorbent portion for passage of the tube. 60. A fixation device according to any one of paragraphs 56 to 59.

[0143] <Paragraph 61> the proximal surface extends in a plane perpendicular to the longitudinal direction of the tube passage through the absorbent; A fixation device according to any one of paragraphs 56 to 60.

[0144] <Paragraph 61.1> The absorbent comprises an antibacterial agent; Optionally, the absorbent is configured to provide fluid communication between the patient and the antimicrobial agent when the mounting pad is attached to the skin of the patient. A fastening device according to any one of paragraphs 48 to 61.

[0145] <Paragraph 61.2> The mounting pad optionally comprises an antimicrobial agent in an adhesive layer of the mounting pad. 10. A fixation device according to any one of paragraphs 1 to 61.1.

[0146] <Paragraph 61.3> the mounting pad is configured to provide fluid communication between the patient and the antimicrobial agent when attached to the skin of the patient; Fixation devices as described in paragraph 61.2.

[0147] <Features of other sleeves> <Paragraph 62> when coupled to the mounting pad, the proximal end of the fixation sleeve has a fixed position relative to the mounting pad; Optionally, a distal end of the fixation sleeve does not have a fixed position relative to the mounting pad. 10. A fixation device according to any one of paragraphs 1 to 61.3.

[0148] <Paragraph 63> The fixation sleeve is configured to change a maximum cross-sectional dimension (e.g., a diameter of a circular cross-section) of the passage cross-sectional area by at least 10 percent relative to a maximum expanded size of the passage cross-sectional area. 63. A fixation device according to any one of paragraphs 1 to 62.

[0149] <Paragraph 64> The fixation sleeve is configured to vary the maximum cross-sectional dimension of the passage cross-sectional area (e.g., diameter of a circular cross-section) by at least 1 millimeter, preferably at least 1.5 millimeters. 64. A fixation device according to any one of paragraphs 1 to 63.

[0150] <Paragraph 65> the fixation sleeve is configured to retain within the fixation portion a portion of the medical tube having a maximum medical outer cross-sectional dimension transverse to the longitudinal direction of the medical tube, preferably the medical outer cross-section of the medical tube is a circular cross-section and the maximum medical outer cross-sectional dimension is an outer diameter of the circular cross-section of the medical tube; the fixation sleeve is configured to vary a maximum cross-sectional dimension of a passage cross-sectional area (e.g., a diameter of a circular cross-section) over a range having a lower limit of at least 1 millimeter less, optionally at least 1.5 millimeters less, than the maximum medical outer cross-sectional dimension, to an upper limit of at least 1 millimeter greater, optionally at least 1.5 millimeters greater, than the maximum medical outer cross-sectional dimension; Optionally, the lower limit is no more than 2 millimeters less than the maximum medical outer cross-sectional dimension; Optionally, the upper limit is no more than 2 millimeters greater than the maximum medical outer cross-sectional dimension. 65. A fixation device according to any one of paragraphs 1 to 64.

[0151] <Paragraph 66> The tube passage has a circular cross-sectional area. 66. A fixation device according to any one of paragraphs 1 to 65.

[0152] <Paragraph 67> the fastening portion of the fastening sleeve is made of a textile (e.g., having a braided, woven, knitted, crocheted, knotted, tutted, felted, or intertwined fiber bond structure); Optionally, the fastening part is coated with and / or doped to release a hygiene component selected from the group consisting of antimicrobials and / or antiseptics. 67. A fixation device according to any one of paragraphs 1 to 66.

[0153] <Paragraph 68> the fabric is made from a construction material selected from the group consisting of metallic materials, polymeric materials, and combinations thereof; Preferably, the construction material comprises a polymeric material, and optionally, the construction material comprises a polymeric material selected from the group consisting of polyethylene terephthalate, nylon, and polyester. 68. The fixation device according to paragraph 67.

[0154] <Paragraph 69> the fixation sleeve is configured to retain within the fixation portion a portion of the medical tube having a maximum medical outer cross-sectional dimension transverse to the longitudinal direction of the medical tube, preferably the medical tube having a circular cross-section, the medical outer cross-sectional dimension being an outer diameter of the circular cross-section; the fixation portion of the fixation sleeve has a length in the longitudinal direction along the fixation sleeve that is at least 5 times, preferably at least 10 times, more preferably at least 12 times, and optionally up to 30 times, preferably up to 25 times, and more preferably up to 20 times, the maximum medical outer cross-sectional dimension, and one preferred range for an outer diameter of the medical tube of 5 millimeters is 6 to 10 centimeters; 69. A fixation device according to any one of paragraphs 1 to 68.

[0155] <Products and Kits> <Paragraph 70> A medical tube fixing product, the product comprising: 70. The fixation device of any one of paragraphs 1-69, wherein the mounting pad comprises an adhesive surface configured to adhere the mounting pad to the skin of the patient; a peelable backing adhered to and covering the adhesive surface, the peelable backing being configured to be peeled from the adhesive surface to expose the adhesive surface for attachment of the mounting pad to the skin of the patient; Equipped with Optionally, the adhesive surface comprises an acrylic adhesive, and optionally the adhesive is impregnated with an antimicrobial agent. product.

[0156] <Paragraph 71> The fixation device comprises an absorbent portion according to any one of paragraphs 56 to 61.1, wherein a peelable backing covers a proximal surface of the absorbent portion, the peelable backing being configured to expose at least a portion, and optionally all, of the proximal surface of the absorbent portion when the peelable backing is peeled away from the adhesive surface; Optionally, the releasable backing contacts the absorbent. The product described in paragraph 70.

[0157] <Paragraph 72> the adhesive surface of the mounting pad has a surface area equal to the surface area of ​​the adhesive pad, with an upper limit of at least 25 square centimeters, preferably at least 45 square centimeters, preferably at least 90 square centimeters; A product as described in paragraph 70 or 71.

[0158] <Paragraph 73> The releasable backing is not adhered to the proximal surface of the absorbent portion. 73. The product described in any one of paragraphs 70 to 72.

[0159] <Paragraph 74> the article further comprises a hermetically sealed housing having the fastening device disposed therein, the fastening device having the releasable backing adhered to an adhesive surface of the mounting pad; Preferably, the fixation device within the housing and the internal environment within the housing are sterile. 74. The product described in any one of paragraphs 70 to 73.

[0160] <Paragraph 75> A kit as a medical tube securement kit, optionally a medical drainage tube securement kit, said kit comprising: A fixation device according to any one of paragraphs 1 to 69, optionally included in a medical tube fixation product according to any one of paragraphs 70 to 74, or alternatively, optionally, not included in the medical tube fixation product according to any one of paragraphs 70 to 74; At least one additional component selected from the group consisting of (i) to (x) below; (i) to (x) are (i) a medical tube that is translatable through the tube passage when the passage cross-sectional area of ​​the tube passage in the stationary portion of the fixation sleeve is in an expanded configuration, the medical tube being configured to be grasped and held by the stationary portion when the passage cross-sectional area of ​​the tube passage in the stationary portion of the fixation sleeve is in a contracted configuration, and optionally an introducer trocar for the medical tube; (ii) a tissue penetration instrument configured to penetrate tissue to provide a sized surgical pathway for insertion of the medical tube secured by the fixation device, optionally selected from the group consisting of a trocar, a tendon passer, and combinations thereof; (iii) a fluid collection system configured to be fluidly connected to a distal end of the medical tube secured by the securing device to collect biological fluid discharged through the medical tube, optionally comprising a collection container configured to collect and hold collected biological fluid, alternatively or additionally, optionally comprising a fluid discharge container (e.g., a valved discharger such as a HEMOVAC® mini-discharger or a bellows-type discharger) configured to initially collect biological fluid and discharge the biological fluid from a discharge container (optionally into another fluid container) and be compressible to apply vacuum suction to the medical tube; (iv) an absorbent pad (separate from the retention device) configured to absorb exudate prior to or as a result of insertion of a medical drain secured by the retention device, and optionally having any one or more of the features described with respect to the absorbent portion of the retention device; (v) a disinfectant wipe (e.g., an alcohol wipe) for cleaning the area around the patient where the medical tube is inserted to be secured by the securing device; and (vi) a skin preparation wipe for preparing the skin of the patient for attachment of the mounting pads of the fixation device, and optionally for preparing the skin for improved adhesion between the mounting pads of the fixation device and the skin; (vii) the compression retainer of any one of paragraphs 28-38 and 47, whether or not it is in place to hold the fixation sleeve in the compressed configuration (e.g., the compression retainer may be included in the kit as a separate component from the fixation device and installed on the fixation device as needed to hold the fixation sleeve in the compressed configuration, or the kit may include the fixation device with the compression retainer pre-installed with the fixation sleeve held in the compressed configuration); (viii) an adhesive component (e.g., benzoin-containing formulations, Mastosol® liquid adhesive), optionally in a wipe or ampoule, for application to the skin to aid in adhesion of the mounting pad to the skin; (ix) an antimicrobial agent for antimicrobial treatment of the patient's skin in the vicinity of where the fixation device is or will be attached to the skin, optionally provided in a form selected from the group consisting of creams, ointments, wipes, and combinations thereof; (x) any combination of two, three, four, five, six, seven, eight, or nine of (i) to (ix); and when any of components (i) through (ix) are included in the kit, the kit comprises at least one such component, but may include multiple such components (e.g., multiple absorbent pads, disinfectant wipes, skin pre-treatment wipes, ampoules or wipes having an adhesive component, or wipes or other forms having an antibacterial agent).

[0161] <Paragraph 76> the medical tubing is disposed through the tube passage; 76. The kit according to paragraph 75.

[0162] <Paragraph 77> a cross-sectional area of ​​the fixation portion is in an expanded configuration where the medical tube is not gripped and held by the fixation portion of the fixation sleeve; 77. The kit according to paragraph 76.

[0163] <Paragraph 78> a cross-sectional area of ​​the retention portion in a contracted configuration with the medical tube gripped and held by the retention sleeve retention portion; 77. The kit according to paragraph 76.

[0164] <Paragraph 79> the medical tube is held by the fixture up to a tensile load applied to the medical tube at a distal face of the distal end of the fixture of at least 7 Newtons, preferably at least 10 Newtons. 79. The kit according to paragraph 78.

[0165] <Paragraph 80> the fixation sleeve is held in a bent configuration having a bend in the fixation sleeve; The bent portion of the fixed sleeve is a corresponding bend in the tube passage through the retention sleeve; and a corresponding bend in the medical tubing disposed through the tubing passage; and , 80. The kit according to paragraph 79.

[0166] <Paragraph 81> At least a portion of the bend in the tube passage is present in the fixing portion of the fixing sleeve; The fastener grips and holds the bent portion of the medical tube. 81. The kit according to paragraph 80.

[0167] <Paragraph 82> in the bent configuration, the medical tube is held by the fixture up to a tensile load of at least 10 Newtons, preferably at least 15 Newtons, applied to the medical tube at a distal face of the distal end of the fixture; 82. The kit according to paragraph 81.

[0168] <Paragraph 83> the fixation sleeve being releasable from being held in the bent configuration; in the bent configuration, the medical tube is held by the fixation portion to a tensile load applied to the medical tube that is at least 20 percent greater, preferably at least 30 percent greater, than the corresponding applied tensile load when the fixation sleeve is released from the bent configuration, and optionally not 100 percent greater than the corresponding applied tensile load when the fixation sleeve is released from the bent configuration; 83. A kit according to paragraph 81 or paragraph 82.

[0169] <Paragraph 84> The fixation sleeve is engaged with the curved sleeve holder of the fixation device according to any one of paragraphs 2 to 27, the bent sleeve holder holds the fixation sleeve in a bent configuration; 84. The kit according to paragraph 83.

[0170] <How to use> <Paragraph 85> 1. A method of securing a medical tube to a patient using a securement device, comprising: the fixation device having a variable length fixation sleeve and a tube passageway through the fixation sleeve for receiving the medical tube for fixation; the fixation sleeve includes a fixation portion, a passage cross-sectional area of ​​the tube passageway across a longitudinal path of the tube passageway at the fixation portion that increases as the fixation sleeve shortens and decreases as the fixation sleeve lengthens, the length of the fixation sleeve being adjustable to increase the passage cross-sectional area to receive the medical tube for translation through the tube passageway and decrease the passage cross-sectional area to grip the medical tube within the tube passageway at the fixation portion to secure the medical tube to the fixation device, the method comprising: gripping the medical tube within the tube passage with the fixation portion of the fixation sleeve while the medical tube extends through the tube passage into the patient's body; Optionally, the fixation device is according to any one of paragraphs 1-69; Further optionally, the fixation device is provided in a product or kit according to any one of paragraphs 70 to 84. method.

[0171] <Paragraph 86> The method further includes bending the retention sleeve into a bent configuration while the medical tube is gripped by the retention portion within the tube passage, thereby imparting a corresponding bend to the medical tube within the tube passage within the retention sleeve. 86. The method according to paragraph 85.

[0172] <Paragraph 87> In the bent configuration, the fixation sleeve, and the medical tube within the tube passage within the fixation sleeve, are bent through an angle of at least 60°, preferably at least 80°, and more preferably at least 90° between longitudinal ends of the fixation sleeve. 87. The method according to paragraph 86.

[0173] <Paragraph 88> The method further includes securing the fixation sleeve in the bent configuration with the medical tube disposed therethrough. 87. The method according to paragraph 86 or 87.

[0174] <Paragraph 89> the fixation device comprises a bent sleeve holder selectively engageable and disengageable with the fixation sleeve to selectively retain and not retain the fixation sleeve in the bent configuration; The step of fixing the fixation sleeve in the bent configuration includes engaging the fixation sleeve with the bent sleeve holder to hold the fixation sleeve in the bent configuration. 89. The method according to paragraph 88.

[0175] <Paragraph 90> The bent sleeve holder is as described in any one of paragraphs 2 to 27. 89. The method according to paragraph 89.

[0176] <Paragraph 91> The method further comprises adjusting the radial position of the bent sleeve holder relative to the fixed sleeve, preferably by a radial distance of at least 5°, optionally prior to bending. 91. The method according to any one of paragraphs 89 to 90.

[0177] <Paragraph 92> the step of adjusting the radial position of the bent sleeve holder is performed prior to engaging the fixation sleeve with the bent sleeve holder to secure the fixation sleeve in the bent configuration. 92. The method according to paragraph 91.

[0178] <Paragraph 93> the step of adjusting the radial position is performed prior to the step of gripping the medical tube within the tube passage with the fixation portion of the fixation sleeve. 93. The method according to paragraph 91 or 92.

[0179] <Paragraph 94> the step of adjusting the radial position is performed while the medical tube is gripped within the tube passage by the fixation portion of the fixation sleeve. 93. The method according to paragraph 91 or 92.

[0180] <Paragraph 95> The step of adjusting the radial position includes: The method includes rotating the rotating member relative to the base member of the fixation device according to any one of paragraphs 19 to 26. 95. The method according to any one of paragraphs 91 to 94.

[0181] <Paragraph 96> the method further comprising the step of locking the curved sleeve holder in place at the selected radial position using a radial positioning lock of the fixing device after adjusting the radial position; Optionally, the step of locking the bent sleeve holder comprises selectively engaging corresponding interlocking first and second locking structures of the base member and the rotating member as described in paragraph 20 or 21. 96. The method according to any one of paragraphs 91 to 95.

[0182] <Paragraph 97> the fixation sleeve has a proximal end disposed toward where the medical tube enters the body of the patient and a distal end opposite the proximal end; a portion of the medical tube within the fixation sleeve has a maximum cross-sectional dimension transverse to the longitudinal direction of the medical tube (e.g., an outer diameter of a circular tube), and in the bent configuration, at least a portion of the medical tube within the tube passageway within the fixation sleeve distal to a bend (bend) in the tube is maintained within a standoff distance from the patient's body of no more than 10 times, preferably no more than 7 times, and more preferably no more than 6 times the maximum medical outer cross-sectional dimension, optionally at least 3 times, or even at least 4 times the maximum medical outer cross-sectional dimension; 97. The method according to any one of paragraphs 86 to 96.

[0183] <Paragraph 98> The method further comprises releasing the fixation sleeve from the bent configuration. 98. The method according to any one of paragraphs 88 to 97.

[0184] <Paragraph 99> The method further includes releasing the medical tube from grip by the fixation portion by applying the longitudinal compression to the fixation portion after releasing the fixation sleeve from the bent configuration. 99. The method according to paragraph 98.

[0185] <Paragraph 100> The method further comprises removing the medical tube from the patient and the fixation sleeve while applying the longitudinal compression; The method optionally includes removing the fixation device from the patient after removing the medical tube. 99. The method according to paragraph 99.

[0186] <Paragraph 101> The method further comprises: removing the fixation device from the patient; removing the medical tube from within the patient while the medical tube is grasped by the fixation portion of the fixation sleeve; Equipped with The method optionally further comprises: during disconnection of the medical tube, and optionally during removal of the medical tube, the medical tube is maintained in the bent configuration described in any one of paragraphs 86-97; prior to removal of the medical tube, the medical tube was in the bent configuration described in any one of paragraphs 86-97, and the medical tube is released from the bent configuration, wherein during removal of the medical tube, and optionally during removal of the medical tube, the medical tube is not in the bent configuration; having a member selected from the group consisting of 99. The method according to any one of paragraphs 85 to 98.

[0187] <Paragraph 102> The method further comprises, after applying the longitudinally applied compression, carrying out a step selected from the group consisting of: (i) repositioning the medical tube within the fixture and gripping the repositioned medical tube with the fixture to adjust a position of the medical tube within the patient, the gripping of the medical tube with the fixture then bending the fixation sleeve with the repositioned medical tube and fixing the fixation sleeve in the bent configuration; (ii) removing the medical tube from the patient and the fixation sleeve and inserting a new medical tube through the fixation sleeve into the patient and then bending the fixation sleeve along with the new medical tube and fixing the fixation sleeve in the bent configuration; (iii) adjusting the radial position of the bent sleeve holder according to any one of paragraphs 89 to 96 to a new radial position and locking the bent sleeve holder in place at the new radial position, and then bending the fixation sleeve carrying the medical tube into the bent configuration and fixing the fixation sleeve in the bent configuration with the bent sleeve holder in the new radial position; 100. The method of paragraph 99, wherein

[0188] <Paragraph 103> prior to the step of gripping the medical tube with the fixation portion, the fixation sleeve with the medical tube disposed therethrough is held in a compressed configuration by a compression retainer, wherein in the compressed configuration, the fixation portion of the fixation sleeve is under an applied compression in the longitudinal direction as a result of the compression retainer; Optionally, the compression retainer is of the fixation device according to any one of paragraphs 28 to 38; and wherein the step of gripping the medical tube with the fastener comprises manipulating the compression retainer, optionally by disengaging the compression retainer from the fastener device, to grip the medical tube with the fastener by releasing the fastener sleeve from the compressed configuration, thereby contracting a passage cross-sectional area of ​​the tube passage within the fastener. 13. The method according to any one of paragraphs 85 to 102.

[0189] <Paragraph 104> The method further comprises attaching the fixation device to the skin of the patient via the attachment pad of the fixation device, optionally via the attachment pad of the fixation device according to any one of paragraphs 1 to 69; Preferably, the step of attaching the fixation device to the skin comprises adhering the mounting pad to the skin using an adhesive. 104. The method according to any one of paragraphs 85 to 103.

[0190] <Paragraph 105> Prior to the step of attaching the fixation device to the skin, an adhesive surface of the mounting pad is covered with a releasable backing; The step of attaching the fixation device to the skin comprises: removing the peelable backing to expose an adhesive surface; adhering the mounting pad to the skin with an adhesive on the adhesive surface; Equipped with 105. The method according to paragraph 104.

[0191] <Paragraph 106> The mounting pad includes an absorber. the step of attaching the fixation device to the skin comprises holding the absorbent portion adjacent to the skin; Preferably, the absorbent section has an opening for receiving the medical tube when the medical tube has been inserted into the patient's body through the fixation sleeve, and the absorbent section surrounds the medical tube passing through the opening to absorb exudate from the patient. 106. The method according to paragraph 104 or 105.

[0192] <Paragraph 107> the absorbent portion is positioned towards and optionally in contact with the patient, the absorbent portion having a fluid communication surface in fluid communication with the patient for absorbing exudate from the patient when the mounting pad is attached to the skin of the patient; the fluid communication surface of the absorbent is covered by the peelable backing prior to removal of the peelable backing; said step of removing said peelable backing exposes said fluid communication surface of said absorbent; 107. The method according to paragraph 106.

[0193] <Paragraph 108> the mounting pad comprises a structural sheet; Prior to removing the peelable backing, the absorbent portion is disposed between the structural sheet and the peelable backing. 108. The method according to paragraph 106 or 107.

[0194] <Paragraph 109> the mounting pad includes a perforated layer of adhesive on the proximal surface of the absorbent portion that faces the patient when the mounting pad is attached to the skin; Perforations through the perforated layer of adhesive provide fluid communication across the perforated layer of adhesive to the absorbent section such that when the mounting pad is attached to the skin of the patient, flow of exudate from the patient across the perforated layer of adhesive is absorbed by the absorbent section. 109. The method according to paragraph 107 or 108.

[0195] <Paragraph 110> Prior to removing the peelable backing, the perforations are covered by the peelable backing; the perforations are exposed when the peelable backing is removed during removal of the peelable backing; 109. The method according to paragraph 109.

[0196] <Paragraph 111> The fixation device is according to any one of paragraphs 48 to 61.1, The fixation device comprises an absorbent portion; Optionally, the fixation device is present in a product or kit according to any one of paragraphs 70 to 84. 111. The method according to any one of paragraphs 106 to 110.

[0197] <Paragraph 112> The method may further comprise preparing a site on the patient for attachment of the mounting pad to the patient prior to attaching the mounting pad to the patient to secure the medical tube to the site, the step of preparing the site comprising: (a) optionally using a preparation wipe of the kit described in paragraph 75, treating the skin at the site with the preparation wipe to improve the surface of the skin for adhesion to the mounting pad; (b) optionally using a tissue penetrating instrument of the kit described in paragraph 75, surgically creating an opening at the site on the patient to accept insertion of the medical tube; (c) optionally using an adhesive component of the kit described in paragraph 75, applying the adhesive component to the skin at the site to assist in adhering the mounting pad to the skin; (d) cleaning the site with a disinfectant, optionally by using a disinfectant wipe of the kit described in paragraph 75; (e) optionally treating the site with an antimicrobial agent by using the antimicrobial agent of the kit described in paragraph 75; and Any combination of two, three, four, or five of items (a) to (e); comprising steps selected from the group consisting of: 12. The method according to any one of paragraphs 104 to 111.

[0198] <Paragraph 113> The method comprises the steps of item (b), The surgical opening accesses an anatomical region selected from the group consisting of intracranial, brain, stomach, small intestine, trachea, heart (e.g., atrium, ventricle), aorta, vena cava, intraperitoneal, thoracic, intramuscular, subcutaneous, colon, kidney, ureter, and bladder; 13. The method according to paragraph 112.

[0199] <Manufacturing method> <Paragraph 114> 1. A method of making a fastening device or a product comprising said fastening device, comprising the steps of: the fixation device is configured to secure the medical tube to the patient when inserted into the patient; Optionally, the fixation device is according to any one of paragraphs 1-69, and the method further comprises: a step of coupling the fastening sleeve to a structural sheet for the mounting pad, optionally coupled to the mounting pad according to any one of paragraphs 1 to 69, the fixation sleeve includes a fixation portion with the tube passage extending therethrough, a cross-sectional passage area of ​​the tube passage at the fixation portion transverse to a longitudinal path of the tube passage increasing as the fixation sleeve shortens and decreasing as the fixation sleeve lengthens, the length of the fixation sleeve being adjustable to increase the cross-sectional passage area to receive the medical tube for translation through the tube passage at the fixation portion and decrease the cross-sectional passage area to grip the medical tube within the tube passage by the fixation portion to secure the medical tube to the fixation device; Preferably, the fixation sleeve is constructed of a fabric, and optionally, the fixation sleeve is the fixation sleeve of any one of paragraphs 1 to 69; the structural sheet for the mounting pad is configured to have a proximal surface that faces the patient in use and a distal surface that faces away from the patient in use, the proximal surface being configured to be adhesively adhered to the skin of the patient; The step of coupling the fastening sleeve to the structural sheet comprises: securing a flared end material adjacent a proximal end of the fixation sleeve between a first surface of a first fixation member and a second surface of a second fixation member; the first securing member is selected from the group consisting of: the structural sheet, the first surface being present on a distal surface of the structural sheet; and an intermediate member coupled directly or indirectly to the distal surface of the structural sheet; Optionally and preferably, the second fixing member is the base member according to any one of paragraphs 19 to 26. method.

[0200] <Paragraph 115> The step of securing the flared end material between the first surface and the second surface comprises: sandwiching the flared end material between a first surface and a second surface; adhering the flared end material to both the first surface and the second surface; Equipped with 115. The method according to paragraph 114.

[0201] <Paragraph 116> Prior to the step of sandwiching the flared end material between a first surface and a second surface, the adhesive is applied to at least one, and preferably both, of the first surface and the second surface. 116. The method according to paragraph 115.

[0202] <Paragraph 117> the adhesive applied is a pressure sensitive adhesive; said step of adhering said flared end material to both said first surface and said second surface comprises pressing said first surface and said second surface together with sufficient pressure to activate said pressure sensitive adhesive thereby adhering said flared end material to said first surface and said second surface; Preferably, the pressure is at least 60 kilopascals (kPa). 117. The method according to paragraph 116.

[0203] <Paragraph 118> The method comprises: connecting the rotating member, optionally as described in any one of paragraphs 19 to 26, to a preliminary product form for the fastening device, the preliminary product form comprising a structural sheet, the rotating member being rotatable relative to the structural sheet when connected to the preliminary product form, Optionally and preferably, the pre-product form comprises the base member according to any one of paragraphs 19 to 26, the step of connecting the rotating member to the pre-product form comprises engaging the rotating member with the base member; The rotating member is rotatable relative to the base member, the rotatable connection between the base member and the rotating member is such that the rotating member is rotatable relative to the base member; Preferably, said step of connecting said rotating member to said pre-product form comprises: following any action pursuant to any of paragraphs 114 to 117, 118. The method according to any one of paragraphs 114 to 117.

[0204] <Paragraph 119> The step of connecting the rotating member to the pre-product form comprises: sliding the rotating member over the fixed sleeve disposed through an aperture in the rotating member until the rotating member engages a connection location on the pre-product form; Preferably, the connection location is on the base member. 119. The method described in paragraph 118.

[0205] <Paragraph 120> connecting the rotating member to the pre-product form comprises engaging the rotating member with an external engagement feature of an axle; When engaged with the axle, the rotating member is rotatable about the axle; Optionally and preferably, the mandrel comprises at least a portion of the extension of the base member according to paragraph 25. 118. The method according to paragraph 118 or 119.

[0206] <Paragraph 121> the mandrel has an aperture extending therethrough in the longitudinal direction; Preferably, the opening extends in the longitudinal direction through the extending portion of the base member; the pre-product form includes a locking sleeve extending through the opening in the mandrel and preferably through the extension portion of the base member; When engaged with the axle, the rotating member is allowed to rotate about the fixed sleeve. 121. The method according to paragraph 120.

[0207] <Paragraph 122> The method further comprises the step of retaining a distal end portion of the fixation sleeve in a distal collar assembly, optionally as described in any one of paragraphs 45 to 47, The step of optionally holding the distal end of the fixing sleeve is performed after connecting the rotating member to the preliminary product form described in any one of paragraphs 118 to 121. 122. The method according to any one of paragraphs 114 to 121.

[0208] <Paragraph 123> The step of retaining the distal end of the fixation sleeve within the distal collar assembly includes: inserting a collar nipple into the distal end of the fixation sleeve; placing a retaining member over the distal end of the fixation sleeve to bias a sleeve wall at the distal end toward the collar nipple; Equipped with 123. The method according to paragraph 122.

[0209] <Paragraph 124> The method further comprises attaching an absorbent pad to a proximal surface of the structural sheet; Optionally, the absorbent pad provides an absorbent portion according to any one of paragraphs 48 to 61.1. 124. The method according to any one of paragraphs 114 to 123.

[0210] <Paragraph 125> The step of attaching the absorbent pad to the proximal surface of the structural sheet comprises: applying an adhesive, preferably a pressure sensitive adhesive, to the proximal surface of the structural sheet; positioning the absorbent pad over at least a portion of the adhesive on the proximal surface of the structural sheet after applying the adhesive; attaching the absorbent pad to the proximal surface of the structural sheet with the adhesive; Equipped with 125. The method according to paragraph 124.

[0211] <Paragraph 126> The method further comprises: after positioning the absorbent pad over at least a portion of the adhesive, covering the absorbent pad with a releasable backing, optionally also covering exposed portions of the adhesive on the proximal surface of the structural sheet not covered by the absorbent pad with the releasable backing; adhering the releasable backing to the mounting pad with the absorbent pad disposed between the releasable backing and the structural sheet; Equipped with 126. The method according to paragraph 125.

[0212] <Paragraph 127> the adhesive comprises a pressure sensitive adhesive; the step of attaching the absorbent pad to the proximal surface of the mounting pad comprises applying pressure to the absorbent pad disposed between the proximal surface of the mounting pad and the releasable backing. 127. The method according to paragraph 126.

[0213] <Paragraph 128> The method further comprises: applying compression applied in the longitudinal direction to at least a portion of the fixation sleeve to shorten the fixation sleeve to a compressed configuration; retaining the stationary sleeve in the compressed configuration with a compression retainer; Equipped with 128. The method according to any one of paragraphs 114 to 127.

[0214] <Paragraph 129> The step of retaining the locking sleeve in the compressed configuration comprises: A base member according to any one of paragraphs 114 to 121; A distal collar assembly according to any one of paragraphs 122 or 123; a step of engaging the 129. The method described in paragraph 128.

[0215] <Paragraph 130> The method comprises: completing the fixation device; sealing the fastening device inside a hermetically sealed housing, optionally the fastening device sealed in the hermetically sealed housing is present in a product according to any one of paragraphs 70 to 74; sterilizing the fixturing device, optionally performed prior to sealing the fixturing device, alternatively, optionally performed after sealing the fixturing device (e.g., by irradiation of the fixturing device in a hermetically sealed housing); 130. The method of any one of paragraphs 114 to 129, comprising:

[0216] <Paragraph 131> The method further comprises packaging the fixation device together with at least one additional component for a kit according to any one of paragraphs 75 to 84 in a common packaging enclosure, Optionally, the common packaging housing is a hermetically sealed housing; Alternatively, optionally, the common packaging housing encloses a sealed housing containing the fastening device or the product provided with the fastening device, 131. The method according to paragraph 130.

[0217] <Features of other medical tubes> <Paragraph 132> a portion of the medical tube configured to be received through the fixation portion having a maximum outer cross-sectional dimension (e.g., an outer diameter of a circular tube cross-section) that is greater than a maximum cross-sectional dimension (e.g., an inner diameter of a circular tube cross-section) of the tube passage within the fixation portion when the fixation sleeve is in a relaxed state; 132. The fixation device, product, kit, or method of any one of paragraphs 1 to 131.

[0218] <Paragraph 133> a portion of the medical tube configured to be received through the fastener portion has a maximum outer medical cross-sectional dimension (e.g., diameter of a circular tube cross-section) transverse to the longitudinal direction of the medical tube in a range of 2 to 14 millimeters (6 to 42 French gauge); Optionally, the maximum medical outer cross-sectional dimension is selected from the group consisting of about 2 millimeters (e.g., 6 French gauge), about 3.3 millimeters (e.g., 10 French gauge), about 5 millimeters (e.g., 15 French gauge), about 6.3 millimeters (e.g., 19 French gauge), about 8 millimeters (e.g., 24 French gauge), about 9.3 millimeters (e.g., 28 French gauge), about 10.7 millimeters (e.g., 32 French gauge), and about 14 millimeters (e.g., 42 French gauge). 133. The fixation device, product, kit, or method of any one of paragraphs 1 to 132.

[0219] <Paragraph 134> a portion of the medical tube configured to be received through the fixation sleeve having a circular circumference in a cross section transverse to the longitudinal direction of the medical tube; Preferably, the fluid flow path through the medical tube has a circular cross-section. 134. The fixation device, product, kit, or method of any one of paragraphs 1 to 133.

[0220] <Paragraph 135> The medical tubing is made of a material selected from the group consisting of silicone (polysiloxane), polyethylene, and polyvinyl chloride; A fixation device, product, kit, or method according to any one of paragraphs 1 to 134.

[0221] The foregoing description of the present invention and its various aspects has been presented for purposes of illustration and description. Moreover, the specification is not intended to limit the invention to the form disclosed herein. Thus, variations and modifications commensurate with the above teachings, and the skill and knowledge of the relevant art, are within the scope of the present invention. The embodiments described herein are further intended to describe known modes for carrying out the present invention, and to enable those skilled in the art to utilize the present invention in such or other embodiments and with various modifications as required by the particular application(s) or use(s) of the invention. It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the prior art.

[0222] Unless expressly stated otherwise or necessarily required by context, e.g., based on incompatibility of features, the disclosed devices, kits, systems, and articles of manufacture may comprise additional features not disclosed, including intermediate structures between disclosed structures. References to coupling, attaching, etc. of features or structures include direct coupling, attaching, etc. of the features or structures, and also include indirect coupling, attaching, etc. with one or more additional intermediate structures or features. Disclosing an element or structure as being between other elements or structures does not exclude the inclusion of additional elements or structures that are also between the other elements or structures. Disclosure of process steps and sequences does not exclude that other steps or other sequences of steps are included.

[0223] The terms "comprising," "containing," "including," and "having," and grammatical variations thereof, are intended to be inclusive and non-limiting, and the use of such terms indicates the presence of a stated condition or feature but does not exclude the presence of other conditions or features. The use of the terms "comprising," "containing," "including," and "having," and grammatical variations of these terms, when referring to the presence of one or more components, subcomponents, or materials, also comprises and is intended to disclose the more specific embodiment in which the term "comprising" is used, and is intended to disclose the more specific embodiment in which the term "comprising," "comprising," or "having" (or variations of such terms) is, as the case may be, replaced with any of the narrower terms "consisting essentially of," "consisting of," or "consisting only of" (or any appropriate grammatical variation of such narrower terms). For example, a statement "consisting of" a listed element or elements is intended to comprise and disclose "consisting essentially of" the listed element or elements, as well as more specific narrower embodiments of "consisting of" the listed element or elements. Examples of various features are provided for illustrative purposes, and terms such as "example," "for example," and "for example" are intended to provide non-limiting illustrative examples and are not to be interpreted or understood as limiting a feature or characteristics to a particular example. The term "at least" followed by a number (e.g., "at least one") means that number or more than that number. The term "at least a portion" means all or a lesser portion than all. The term "at least a majority" means a majority portion less than all or less than all.

Claims

1. 1. A fixation device for securing a medical tube to a patient when inserted into the patient, the fixation device comprising: a mounting pad configured to interface with the patient's skin to attach the fixation device to the skin; a variable length fixation sleeve having a proximal end and a distal end at an opposite longitudinal end from the proximal end, the variable length fixation sleeve coupled to the mounting pad via a coupling structure adjacent the proximal end of the fixation sleeve; a tube passageway configured to receive the medical tube for fixation to the patient, the tube passageway extending longitudinally through the fixation sleeve; It is equipped with the fixation sleeve includes a fixation portion through which the tube passage extends, a cross-sectional passage area of ​​the tube passage within the fixation portion transverse to a longitudinal path of the tube passage increasing as the fixation sleeve shortens and decreasing as the fixation sleeve lengthens, the length of the fixation sleeve being adjustable to increase the cross-sectional passage area to receive the medical tube for translation through the tube passage within the fixation portion and decrease the cross-sectional passage area to grip the medical tube within the tube passage by the fixation portion to secure the medical tube to the fixation device; a bent sleeve holder selectively engageable and disengageable with the fixation sleeve to selectively retain and not retain the fixation sleeve in a bent configuration in which the fixation sleeve has a bend along which the tube passage is correspondingly bent; 1. A fixed device comprising:

2. the bent sleeve holder engages at least a longitudinal portion of the fixation portion of the fixation sleeve when the fixation sleeve engages the bent sleeve holder to hold the fixation sleeve in the bent configuration; The fixation device of claim 1 .

3. the bent sleeve holder includes a retaining channel within which a corresponding portion of the fixation sleeve is receivable at a receiving position to hold the fixation sleeve in the bent configuration; The fixation device of claim 2 .

4. the bent sleeve holder is rotatably mounted and is rotatable to a plurality of different radial positions relative to the mounting pad; the bent sleeve holder includes a radial positioning lock that selectively locks the bent sleeve holder at different ones of the plurality of radial positions. The fixation device of claim 1 .

5. The fixation device further comprises: a base member and a rotating member rotatable relative to the base member, the bent sleeve holder being supported on the rotating member; The fixation device of claim 4 .

6. the base member and the rotating member include corresponding interlocking first and second locking structures selectively engageable to lock the radial position of the rotating member at different ones of a plurality of radial positions; The fixation device of claim 5 .

7. The base member includes an extension portion that extends through an opening in the rotatable member, the rotatable member being rotatable about the extension portion. The fixation device of claim 6.

8. the fixation device further comprises a compression retainer positioned to retain the fixation sleeve in a compressed configuration with the fixation portion of the fixation sleeve under the longitudinally applied compression and the passage cross-sectional area in an expanded configuration to receive the medical tube; the compression retainer is operable to release the fixation portion from the longitudinally applied compression to lengthen the fixation sleeve, thereby contracting the passage cross-sectional area to the expanded configuration, thereby enabling the fixation portion to grip the medical tube when positioned through the tube passage through the fixation portion. The fixation device according to any one of claims 1 to 7.

9. the fixation sleeve has a released configuration when the fixation sleeve is released from the compressed configuration with nothing disposed in the tube passageway through the fixation sleeve, the length of the fixation sleeve being greater in the released configuration than in the compressed configuration; a minimum insertion cross-section of the tube passage within the fixation portion across a longitudinal path of the tube passage through the fixation portion varies as the length of the fixation sleeve is varied, the minimum insertion cross-section being greater in the compressed configuration than in the released configuration; the minimum insertion cross section has a maximum cross-sectional dimension; the minimum insertion cross section is configured to receive a corresponding outer medical cross section of the medical tube in the compressed configuration and retain it in the released configuration; the medical outer cross-section has a maximum medical outer cross-sectional dimension; in the released configuration, the maximum cross-sectional dimension of the minimum insertion cross-section is at least 0.5 millimeters less than the maximum medical outer cross-sectional dimension of the medical outer cross-section of the medical tube; The fixation device of claim 8.

10. the coupling structure includes a flared proximal end material of the fixation sleeve sandwiched between a first fixation member and a second fixation member; The fixation device according to any one of claims 1 to 7.

11. the mounting pad includes an absorbent portion configured to absorb exudate during use of the fixation device; The fixation device according to any one of claims 1 to 7.

12. The tube passage extends through an opening in the absorbent. The fixation device of claim 11.

13. the absorbent portion has an absorbent capacity of at least 500% by weight, determined as the absorption for saturation with 0.9% weight / volume saline (isotonic saline) relative to the weight of the absorbent portion; the absorption capacity is at least 1 milliliter, determined as the absorption relative to saturation of 0.9% weight / volume saline (isotonic saline); the absorbent portion has a proximal surface configured to be positioned toward the skin of the patient; the proximal surface of the absorbent has a surface area of ​​at least 4 square centimeters; the fixation device has an opening in the proximal surface of the absorbent portion for the passage of the tube; The fixation device of claim 12.

14. A medical tube fixing product, the product comprising:

13. The fixation device of claim 12, wherein the mounting pad comprises an adhesive surface configured to adhere the mounting pad to the skin of the patient; and a releasable backing adhered to and covering the adhesive surface, the releasable backing configured to be peeled from the adhesive surface and expose the adhesive surface for adhesion of the mounting pad to the skin of the patient; A product comprising: the absorbent portion has a proximal surface configured to be positioned toward the skin of the patient; The releasable backing covers the proximal surface of the absorbent portion and is configured to expose at least a portion of the proximal surface of the absorbent portion when the releasable backing is peeled from the adhesive surface. product.

15. 1. A method of making a retention device or an article of manufacture comprising the retention device, the retention device being configured to secure a medical tube to a patient when the medical tube is already inserted into the patient; The method includes coupling a fastening sleeve to a structural sheet for the mounting pad; the fixation sleeve includes a fixation portion through which the tube passage extends, a cross-sectional passage area of ​​the tube passage within the fixation portion transverse to a longitudinal path of the tube passage increasing as the fixation sleeve shortens and decreasing as the fixation sleeve lengthens, the length of the fixation sleeve being adjustable to increase the cross-sectional passage area to receive the medical tube for translation through the tube passage within the fixation portion and decrease the cross-sectional passage area to grip the medical tube within the tube passage by the fixation portion to secure the medical tube to the fixation device; the structural sheet for the mounting pad is configured to have a proximal surface that faces the patient in use and a distal surface that faces away from the patient in use, the proximal surface being configured to be adhesively adhered to the patient's skin; The step of coupling the fastening sleeve to the structural sheet comprises: securing a flared end material adjacent the proximal end of the fixation sleeve between a first surface of a first fixation member and a second surface of a second fixation member; the first securing member is selected from the group consisting of: a structural sheet such that the first surface resides on the distal surface of the structural sheet; and an intermediate member directly or indirectly coupled to the distal surface of the structural sheet. method.

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